SBIA Resources in Chinese
- FDA’s Office of International Programs- China Office and Small Business and Industry Assistance Program (SBIA) collaboration
- Online availability of resources translated in Chinese
- Webinars recently translated into Chinese
To continually improve its pre-ANDA interactions with applicants for generic drugs
Paragraph IV Patent Certifications
Paragraph IV Certifications List
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Final Guidance Topics
Draft Guidance Topics
identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and related patent and exclusivity information. LEARN
date on which FDA receives patent information from NDA holder (21 C.F.R. 314.53(d)(ii)(5) LEARN
search results and drug listings now show patent submission dates where available; may help generic drug manufacturers determine earliest date for marketing LEARN
Patent– granted by US Patent and Trademark Office anytime during drug development; encompass a wide range of claims.
Exclusivity– granted per FD&C Act. delays and prohibitions on approval of competitor drugs; for NDA and ANDA holders; promote balance between new drug innovation and generic drug competition LEARN
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Image credit: FDA
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New technology platform to allow industry to request FDA pre-ANDA meetings for complex generic drug products
Image credit: FDA
CLIA: Clinical Laboratory Improvement Amendments
CLIA IVD Categorization:
CLIA Waiver by Application:
Image credit: FDA
Sentinel is used by the FDA-CDER to assess the safety of prescription drugs, including biological therapeutics and generic drugs
Image credit: Sentinel/FDA
Harvey, Irma, and Maria
Address safety and shortages
Gain access to health coverage immediately
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Highly interactive web-based tool for FAERS data
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To address growing epidemic of opioid abuse, dependence and overdose in the US
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During natural disasters medical devices may be exposed to fluctuating power, contaminants, or unusual levels of heat or humidity.
FDA provides information on using medical devices during and following emergency situations
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President signed into law the Food and Drug Administration Reauthorization Act (FDARA)
Drug User Fees
Medical Device User Fees
Office of Generic Drugs (OGD) providing update to improve transparency related to Generic Drug User Fee Amendments of 2012 (GDUFA)
Image credit: FDA
Expanded Access Navigator launched by Reagan-Udall Foundation in collaboration with patient advocacy groups, pharmaceutical industry, FDA, and Federal government
Image Credit: Reagan-Udall Foundation for the FDA
FDA announced the Digital Health Innovation Action Plan
Additional information can be found on the Digital Health Webpage
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FDA reimagining oversight of digital health technology
“Software Precertification (PreCert) Pilot Program.” – new pilot program
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“Purple Book” lists biological products, including any biosimilar and interchangeable biological products
The 21st Century Cures Act (Cures Act) signed into law on December 13, 2016
Newly created webpage details FDA plans and progress
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FDA working to implement 2016 Cures Act to advance medical innovation
Regulatory science projects underway and how they advance public health
For health care professionals, scientists, and engineers
For regulatory science training, conduct cutting edge research on targeted scientific, policy, or regulatory issues under FDA senior scientist mentorship
Application deadline: July 7, 5 pm EST
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Image credit: FDA
Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. (1972)
New Mobile NDC App for quick directory searches
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Drug Information Soundcast in Clinical Oncology (DISCO)
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Product’s Intended Use determines regulation as Drug, Cosmetic, or Both
Pregnancy Exposure Registry enrollment can help (1) improve medicine safety information and (2) update drug labeling
Picture source: Google
Health Disparities refer to differences in the health status of different groups of people
Office of Minority Health (OMH) Research and Collaboration program strengthening the FDA’s ability to identify and address these disparities
Important to properly dispose unused drugs to help reduce harm from accidental exposure or intentional misuse
FDA review shows increased risk of serious pancreatitis in patients without a gallbladder
FDA BRIEF: Week of March 27, 2017
Tesaro, Waltham, MA, USA
INDICATION: Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy
ADDRESSING UNMET NEED:
REG PATHWAY: NDA
MECHANISM OF ACTION: Inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair
Regeneron Pharmaceuticals, Tarrytown, NY, USA
INDICATION: Treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids
ADDRESSING UNMET NEED:
REG PATHWAY: BLA
MECHANISM OF ACTION: Human monoclonal IgG4 antibody, inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13), inhibits cytokine-induced responses, including the release of proinflammatory cytokines, chemokines and IgE
Genentech, Member of Roche Group, San Francisco, CA, USA
INDICATION: Treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis (PPMS)
ADDRESSING UNMET NEED:
REG PATHWAY: BLA
MECHANISM OF ACTION: Binding to CD20, resulting in antibody-dependent cellular cytolysis and complement-mediated lysis
Brain Sentinel, San Antonio, TX, USA
INDICATION FOR USE: Adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest.
The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure.
The System records and stores sEMG data for subsequent review by a trained healthcare professional
REG PATHWAY: De Novo request
GENERIC DEVICE DESCRIPTION: Non-invasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure
RISKS & MITIGATIONS:
Join a multi-disciplinary team to pursue next generation sequencing and molecular biology translational research in order to understand complex regulatory and scientific questions in oncology. Multiple projects collaborating with outside academic or government institutions will be pursued. As many of the projects will be performed using next generation sequencing technology, experience in this technique will be key.
Promotes and Protects Public Health by:
Managed by Office of Health and Constituent Affairs, Office of Commissioner
FDA Patient Representatives
CRITICAL PATH INNOVATION MEETINGS (CPIM)
Biomarkers In Development of FDA-Approved Therapeutics
October 2007- December 2015
|Anesthesiology||T1*; magnitude of T4/T1* ratio by acceleromyography|
|Serum low-density lipoprotein (LDL-C)|
|Ecarin clotting time; activated partial thromboplastin time; thrombin time; activated clotting time; plasma diluted thrombin time|
|Infectious Disease||Hepatitis C virus (HCV) RNA*|
|Human immunodeficiency virus (HIV)-1 RNA|
|Sputum culture conversion to negative|
|Parasite count resolution|
|Inborn Errors of Metabolism||White blood cell count; neutrophil count; red blood cell count; mean corpuscular volume|
|Growth in height or weight|
|Forced vital capacity (FVC)|
|Plasma ammonia; plasma glutamine; and plasma citrulline|
|Splenic volume by magnetic resonance imaging (MRI)|
|Metabolism and Endocrinology||Body weight|
|Bone mineral density by DEXA* scan|
|Serum calcium; oral calcium supplements; oral vitamin D supplements|
|Urinary free cortisol (UFC)|
|Vertebral fractures by X-ray|
|Visceral adipose tissue (VAT) by computed tomography (CT) scan|
|Oncology||CD34 positive cell count|
|Complete blood count (e.g., absolute neutrophil count)|
|Tumor burden by Bcr-Abl* (Philadelphia chromosome)|
|Tumor burden by Philadelphia chromosome positive cells|
|Tumor burden by imaging (using criteria such as RECIST* or EBMT*)|
|Ophthalmology||Anterior chamber cells|
|Intraocular pressure (IOP)|
|Vitreomacular adhesion (VMA) by optical coherency tomography|
|Pulmonology||Forced expiratory volume in one second (FEV1)|
|Respiratory distress syndrome (RDS) by chest X-ray and fraction of inspired oxygen (FiO2)|
|Transplant||Biopsy-proven acute rejection (BPAR)|
|Medical Imaging||Qualitative assessment of cerebral distribution of radioactive signal|
|Qualitative assessment of radioactive uptake (such as lymph node or tumor detection)|
|Qualitative regional assessment of localized radiographic signal intensity|
|Quantitation of arterial narrowing|
|Radioactive uptake in myocardial segments|
|Semi-quantitative lesion characteristics (such as internal morphology; contrast enhancement; border delineation)|
|Ultrasonographic signal intensity|
The ORISE Research Participation Programs at FDA accept applications from students, recent graduates, and faculty researchers year round.
Each opportunity listed below contains instructions concerning the process for submitting an application and other supporting documents.
Active learning through exercises, instructor-led discussions, and quizzes
Format similar to Harvard Business Review Case Studies
Available Case Studies:
WHY: Described in Section 3033 of the 21st Century Cures Act
WHEN: Either concurrently with IND submission or as an IND amendment
WHO: CBER, Office of Tissues and Advanced Therapies (OTAT)
Clarification of “FDA approved!” claim
DOES NOT approve :
Misuse of FDA’s logo may violate federal law
22 Case Studies with Divergent Phase 2/Phase 3 Results
22 case studies of drugs, vaccines and medical devices since 1999 – No confirmation of:
Drug Safety Oversight Across the Product Lifecycle
Advancing Drug Safety Science
Improving Operations and Management in Support of Drug Safety
Communicating Drug Safety: A Global Public Interface
22 NOVEL DRUGS
Innovative products that serve unmet medical needs/significantly advance patient care. Have chemical structures that have never been approved before.
Adlyxin, Anthim, Axumin, Briviact, Cinqair, Defitelio, Epclusa, Eucrisa, Exondys 51, Lartruvo, Netspot, Nuplazid, Ocaliva, Rubraca, Spinraza, Taltz, Tecentriq, Venclexta, Xiidra, Zepatier, Zinbryta, Zinplava
WHAT: Laboratory developed test (LDT) is in vitro diagnostic test designed, manufactured and used within a single laboratory
WHY: To measure or detect analytes in sample taken from a human body
WHO: Individual labs. However, diagnostic devices not considered to to be LDTs if they are designed or manufactured completely, or partly, outside of the laboratory that offers and uses them.
HOW: FDA does not enforce premarket review as tests are relatively simple. However, FDA concern with some high-risk LDTs (e.g. cancer detection) with unsubstantiated claims, erroneous results, data falsification. Discussion paper issued in Jan 2017
WHAT: Listing and reviews on New Molecular Entities
WHY: Timely disclosure of drug approval to spur innovation and bring new therapies to market
HOW: Timely posting of FDA review summaries, labeling, press releases
WHAT: Guidance documents that CDRH intends to publish in FY2017 & previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn.
WHY: Per MDUFA III negotiations, to help get safe and effective medical devices to market more quickly
HOW: 3 lists
Patient-Reported Outcomes with LASIK (PROWL)
WHAT: Patient experiences, not health care provider, to measure impact symptoms directly had on performing usual activities.
HOW: Pilot, PROWL-1 and PROWL-2 studies
WHAT: Free App to support practitioners who provide medication-assisted treatment (MAT), as well as those who plan to do so in the future.
WHY: 80% of Americans with opioid use disorder do not receive treatment
WHAT: 2 year Government-Industry- Academia Fellowship
WHY: Training on drug information, medication safety, advertising and promotion
WHO: Jointly sponsored by FDA, Purdue university, Eli Lilly , Janssen, J&J
WHEN: 2017-2019 cycle
HOW: Application deadline Dec 14.
WHAT: LASIK Quality of Life Collaboration Project (LQOLCP) to understand potential risk of severe problems from LASIK
WHY: Develop tool to assess patients with difficulties with usual activities and identify predictors
WHO: FDA, National Eye Institute and Department of Defense
HOW: Patient-Reported Outcomes with LASIK (PROWL) studies
FDA BRIEF: Week of Nov. 14, 2016
Orphan Disease R & D Has a Home at FDA
John J. Whyte, MD, MPH, Director, Professional Affairs and Stakeholder Engagement, FDA
Gayatri Rao, MD, JD, Director, Office of Orphan Products Development, FDA
FDA Research on Zika Virus Vaccines and Therapeutics
Neonatal mouse model provides a new platform for Zika virus research
WHAT: MedWatchLearn teaches how to complete the forms necessary to report problems to FDA
WHY: Input is critical for FDA to monitor safety of medical products
WHO: Students, health professionals, and consumers
Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse
WHAT: Chronological information about FDA activities and significant events related to opioids, including abuse and misuse
WHY: Provide details on key events and actions – starting from 1911
WHAT : Resource for timely and related information on neurological medical devices
WHY: Help sponsors and innovators
HOW: Provide information on regulatory process, standards and guidances, regulatory science information, patient perspectives and real world data, webinars, and events of interest
WHAT: 2-year fellowship – Rotations with FDA’s CDER and Industry
WHY: Train selected candidates in one of three tracks focused on the medical and regulatory aspects of drug information dissemination, drug advertising and promotion, or medication safety
WHO: Jointly Sponsored by: FDA, Purdue University, Eli Lilly and Company, Janssen Scientific Affairs, LLC, and Johnson and Johnson
WHEN: Available Positions for 2017 – 2019
WHAT: Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products.
WHY: Easier search, FAQs
WHAT: FDA reporting of allegation of regulatory misconduct of medical device manufacturer or individuals marketing medical devices
WHY: Help FDA identify potential risks to patients, determine whether further investigation is warranted, and identify steps needed to address or correct violation
WHO: Anyone may file a complaint; identity or contact information will not be shared publicly
HOW: Allegations of Regulatory Misconduct Form, by email, or by regular mail.
WHAT: Cluster to share best practices involving patients along drug and biologic regulatory lifecycles
WHY: Broadened approach to advance and strengthen international collaboration
WHO: FDA and European Medicines Agency (EMA)
HOW: Meet up to four times per year
WHAT: For ideas from science and technology experts on next major breakthrough
WHY: FDA preparedness for emerging issues and scientific discoveries years before regulatory submissions
WHO: Private sector
HOW: Submit in public idea portal below.
Dealing with ADHD: What You Need to Know
FDA Approved Treatments
Reduce symptoms and improve functioning in children as young as age 6.
Testing in Younger Kids
Adults and ADHD
WHAT: Website on FDA’s Efforts to Advance Artificial Pancreas Device Systems. Sometimes an artificial pancreas device system is referred to as a “closed-loop” system, an “automated insulin delivery” system, or an “autonomous system for glycemic control.” NOTE: The Artificial Pancreas Device Systems described on this site do not involve biomaterial, synthetic or artificial tissue or organs.
WHY: To advance the development of an artificial pancreas device system, an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in people with diabetes who use insulin.
WHO: FDA along with diabetes patient groups, diabetes care providers, medical device manufactures, and researchers
WHEN: On September 28, 2016, the FDA approved the first hybrid closed loop system, the Medtronic’s MiniMed 670G System, intended to automatically monitor blood sugar and adjust basal insulin doses in people with type 1 diabetes.
WHAT: Bioresearch monitoring web site that makes clinical research information available to the public.
WHY: To foster transparency and encourage information sharing within the clinical research community. Contains information on clinical investigators, contract research organizations, and institutional review boards involved in the conduct of IND studies with human investigational drugs and therapeutic biologics.
HOW: Extracted from IND-related documents for whom FDA has received Form FDA 1572
WHAT: Foundation to efficiently generate evidence for medical device evaluation and regulatory decision-making
WHY: National evaluation system would generate evidence across the total product lifecycle (TPLC), by leveraging real-world evidence (RWE)and applying advanced analytics
WHO: Link and synthesize data across the medical device landscape – clinical registries, electronic health records and medical billing claims
HOW: High quality RWE for health care providers and patients to make better informed treatment decisions; strike right balance between safety vs innovation and patient access
WHAT: Part of Office of Science and Engineering Laboratories (OSEL), CDRH
WHO: Experts in biology, biomaterials science, biomedical and chemical engineering, chemical physics, materials science, pharmacology, physical chemistry, polymer science, and toxicology
HOW: Focus on
WHAT: The FDA’s Oncology Center of Excellence (OCE) formed 2 months ago
WHY: To leverage combined expertise in drugs, biologics, and devices to expedite development of oncology-related medical products and support an integrated review
WHO: Richard Pazdur, M.D.Acting Director
HOW: Oncology meetings hosted by FDA and stakeholders
CERSI Lecture Series
WHAT: Lecture series to present current research and advancements in regulatory science related to pre-clinical evaluation of safety and efficacy of medical products, emerging technologies, and assessing diverse data sets through information sciences to improve health outcomes.
WHO: Centers of Excellence in Regulatory Science and Innovation
HOW: Presented by scientists from the CERSI academic institutions or collaborators of CERSI investigators.
Medical Device Single Audit Program (MDSAP)
WHAT : Invitation to manufacturers to participate in innovative regulatory single audit program.
WHO: MDSAP Regulatory Authority Council
HOW: Learning modules in CDRH Learn – see links below
Inspections – Global Harmonization (New modules 9/8/16)
1. Introduction to MDSAP
2. MDSAP Management
3. MDSAP Device Marketing Authorization and Facility Registration
4. MDSAP Measurement, Analysis and Improvement
5. MDSAP Medical Device Adverse Events and Advisory Notices Reporting
6. MDSAP Design and Development
7. MDSAP Production and Service Controls, part 1
8. MDSAP Production and Service Controls, part 2
9. MDSAP Production and Service Controls, part 3
10. MDSAP Purchasing
WHAT: Drug Safety Labeling Changes (SLC) database provides approved safety labeling changes
WHEN: Data from from January 2016 forward. Prior information at MedWatch website.
WHO: CDER’s Office of Communications – OCOMM
WHY:To more efficiently gather, organize and distribute information related to drug safety label changes. Prompt access to health care providers and consumers to better promote patient health.
HOW: Visit site, Sign up for updates
WHAT: Free Continuing Education Webinars from CDC for Healthcare Providers. CE is available! There are no fees for CE.
WHEN: August 29, 2016 : Invasive Nontuberculous Mycobacterium Infections Associated with Exposure to Heater-Cooler Units during Cardiac Surgery
WHY: Recent reports of suggest that heater-cooler units used in cardiopulmonary bypass procedures, are putting patients at risk for invasive nontuberculous mycobacterium (NTM) infections. CDC offering expert panel to discuss
WHAT: Web-based version of the Orange Book, which identifies drug products approved on the basis of safety and effectiveness by the FDA, first appeared as a published list in October 1980.
WHY: Updated design with new, user-friendly search options that help users customize their research experience.
HOW : Redesigned web page conveniently collects search and browse options onto the home page to improve access of these commonly used features.
WHEN: August 21, 1996, a bipartisan legislation called the Health Insurance Portability and Accountability Act or HIPAA
WHAT: More than medical privacy and security law. Allows transfer and continue health insurance after change or job loss – under Consolidated Omnibus Budget Reconciliation Act (COBRA). Further developed to Affordable Care Act (ACA) amendment and expansion of original HIPAA consumer protections.
WHAT: Information about developing products for rare diseases & conditions
WHO: CDER + Office of Orphan Product Development (OODP)
WHY: Resources for Industry, including Small Business
WHAT: Work collaboratively with a network of 250 hospitals, nursing homes and home health facilities in US
WHY: To assist in detecting, understanding, and sharing information on safety of devices
WHEN: Launched in 2002
HOW: Secure, on-line system for reporting problems with the use of medical devices.
WHAT: Interviews and commentaries are available to communicate important safety information to clinicians.
WHY: Topics related to protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices.
WHO: FDA and Medscape
WHAT: FDA position and guidance on medical device interoperability – ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems.
WHY: Interoperable devices with the ability to share information across systems and platforms can:
WHO: CDRH – along with hospitals, health care providers, manufacturers, standards development organizations, and other interested parties to promote medical device interoperability.
WHAT: Pilot project utilizing the product identifier for product tracing; improving the technical capabilities of the supply chain
WHY: Enhance the security of the pharmaceutical distribution supply chain
WHO: FDA in coordination with authorized manufacturers, repackagers, wholesale distributors, and dispensers
WHAT: Stay up to date with SBIA by receiving updates directly to your LinkedIn feed
WHY: Will post items such as:
WHAT: FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of certain drugs outweigh their risks. FDA has a new and improved REMS@FDA website
WHY: FDA pharmacists show how to navigate FDA’s user-friendly REMS website. The new website makes it easier what is required to prescribe or dispense a drug with a REMS.
WHAT: Toolkit to communicate importance of having minorities participate in clinical trials
WHO: ALL are invited to learn
WHY: Become a “Clinical Trials Champion” to promote “Year of Clinical Trial Diversity”
HOW: Share resources and promote on social media
WHAT: Office of Prescription Drug Promotion
WHY: To protect the public health by ensuring that prescription drug information is truthful, balanced, and accurately communicated.
HOW: Comprehensive surveillance, enforcement, and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers
WHAT ELSE: Bad Ad Program – Truthful Prescription Drug Advertising and Promotion
The Prescriber’s Role – Recognize and Report
WHAT: Design, Tracking, Oversight, Review of studies mandated under section 522, Federal Food, Drug and Cosmetic Act
WHY: To ensure well-designed 522 postmarket surveillance studies, conducted effectively and efficiently in the least burdensome manner
WHEN: Since 2008
WHO: Division of Epidemiology , Office of Surveillance and Biometrics, CDRH
HOW: CDRH Internal Tracking System, PUBLIC WEBPAGE
3D Printing of Medical Devices
WHAT: New webpage on 3D printed medical devices (e.g. orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, external prosthetics). FDA has cleared more than 85 3D printed medical devices!
HOW: FDA standards discussed in presentations, workshops and a new guidance posted in this blog
WHAT: New electronic system to request a Certificate of Pharmaceutical Product (CPP) online as an alternative to a paper submission
WHY: Possible reduction in certificate processing time, a guided step-by-step application process, real-time validation of data, and e-mail notifications of status updates
HOW: Electronic submission procedures guide
WHAT: Listing of current and terminated Emergency Use Authorizations that make available diagnostic and therapeutic medical devices
WHO : CDRH
WHY: To diagnose and respond to public health emergencies
WHAT: To facilitate drug development process by supporting regulatory qualification of biomarker for a particular context of use
HOW: Submit biomarker for qualification
WHAT: To generate evidence across total product lifecycle by leveraging real-world evidence for medical device evaluation and regulatory decision-making
WHY: Quality real-world evidence for health care providers and patients to make informed treatment decisions and balance safety vs device innovation and patient access
WHEN: Initial report in 2012. Included in CDRH 2016-2017 priorities
WHAT: Web-based tool for developers of health-related mobile apps
WHO: Federal Trade Commission (FTC), Dept of Health and Human Services, FDA
WHY: Help developers understand what federal laws and regulations might apply to their apps – FTC Act, HIPAA, FD&C Act
WHAT: Total prohibition on the current and future sales, distribution, and manufacturing of a medical device
WHY: Analyzing and weighing the risks and benefits the device poses to individuals. Can ban a device without actual proof of illness or injury, and only needs to find that a device has the potential to present the required degree of risk based on all available data and information
WHEN: Acts on this authority very rarely. Until 2016, the FDA banned only one other medical device, prosthetic hair fibers. In 2016, FDA proposed ban on powdered gloves on the unreasonable and substantial risk of illness or injury to exposed individuals
HOW: Notice of proposed rulemaking is published in the Federal Register
WHAT: Current update for Health Professionals
WHY: To provide up to date information on medical products for learning and engagement
HOW: Sign up for email alerts
WHAT: CDRH 2016 Experiential Learning Program (ELP) to invite medical device industry, academia, and health care facilities to participate in training program for FDA’s medical device review staff
WHY: CDRH staff training to
NOT a compliance inspection
WHO: Medical device industry, academia, and health care facilities can participate
HOW: Submit electronic or written request for participation
WHAT: Medical Devices Research Program aim to ensure patients have access to high quality, safe and effective medical devices.
WHY: Advance regulatory science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of medical devices and radiation-emitting products.
HOW: Laboratory and field research in the areas of physical, life, and engineering sciences as well as epidemiological research in postmarket device safety. Collaborations with academia, healthcare providers, other government agencies and industry.
WHAT: FDA’s Commissioner’s Fellowship Program Class of 2016
WHEN: Accepting applications from April 1 – May 12, 2016
WHY: FDA invites outstanding health care professionals, scientists, and engineers to apply to its two-year Fellowship Program, where they will receive regulatory science training and the chance to conduct cutting-edge research on targeted scientific, policy, or regulatory issues under the mentorship of an FDA senior scientist.
Questions? E-mail firstname.lastname@example.org
WHAT: New online continuing education course
WHY: Purpose is to educate health care providers, industry, and consumers about basics of the drug regulatory process and the science that supports FDA mission. Provides 1.5 hours of continuing education credit.
WHAT: Formal Review of scientific and/or medical disputes. Related to applications for user fee products. To quickly and impartially investigate complaints and resolve disputes between CDER and CDER-regulated industry, health care practitioners, and consumers by offering an informal, confidential, and neutral environment
HOW: Process codified in Code of Federal Regulations (CFR) and CDER/CBER Guidance for Industry
WHO: FDA contacts:
WHAT: Identifies drug and biologic products for which the sponsor has received a pediatric research Equity Act (PREA) Non-Compliance letter
WHY: Sponsors required to submit pediatric assessments required by PREA as part of drug approval
HOW: Provides links to the PREA Non-Compliance letter and sponsor response. When the sponsor fulfills, FDA will add the date to the last column of the table
WHAT: Paper handouts provided with certain prescription medicines. Contain information to avoid serious adverse events
WHY : FDA requires Medication Guides be issued when Agency determines that certain information is necessary to prevent serious adverse effects
HOW: Inform Patient decision-making by information about known serious side effect, or patient adherence to directions for the use
WHAT: Continuing Education Course for health care professionals to strengthen knowledge and understanding of biosimilars and interchangeable products – which are not generic products
WHY: Growing interest in biosimilars and interchangeable products in the pharmaceutical industry
HOW: Will inform about the development process, approval pathways, and relationships between biosimilars and interchangeable products.
WHAT: Database for oversight and tracking Studies, Requirements and Commitments postapproval.
WHY: Need for oversight. Drug studies, mandated as condition of approval (accelerated approval) or for improving prescribing and use, quality and consistency. Device studies mandated as condition of approval (PMA, PDP. HDE) and to ensure well-designed post-approval studies conducted effectively and efficiently..
HOW: Publicly accessible database. Updated regularly
WHAT: Agency-wide performance management system
HOW: Monitors FDA programs through key performance measures and projects
WHAT: independent assessment of CDRH’s premarket review program
HOW: Process improvements to promote predictable, efficient, and consistent premarket reviews (Phase 1), FDA’s implementation Phase 1 recommendations (Phase 2)
WHAT : MedWatch program makes it easy to get important safety information directly from you to us.
WHO: Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research.
WHAT: Discussion of major events of the past year and priorities for 2016.
WHO: CDER Small Business and Industry Assistance
WHAT: Best Communications Practices with FDA
WHY: Communication between FDA and sponsors during product development and at critical junctures ultimately facilitate earlier availability of safe and effective drugs to the American public.
WHO: AIDSinfo is releasing HIV/AIDS Guidelines app for iOS and Android devices.
WHAT: Provides mobile access to the federally approved HIV/AIDS medical practice treatment guidelines.
WHY: To provide Health Care Providers mobile access to up-to-date HIV information at the point of care—even when Internet connection is unavailable
HOW: AIDSinfo to download the free Guidelines app to your device
WHAT : Drug Industry -specific resources pages focused on information that serves as a guide to key information
WHAT : CELP serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. CELP encourages and supports active participation in forming FDA regulatory policies that promote healthy dietary and nutrition practices and advance the safety and effectiveness of human medical products that treat diabetes, hypertension, heart disease, and obesity.
WHO : Your organization can collaborate with FDA
HOW : Phone: 301-796-8460, Cardio.Endo@fda.hhs.gov
WHAT : Names, addresses, pertinent information FDA inspections of clinical investigators
WHEN : August 1977-present, updated quarterly
WHO : CDER
WHAT : Clinical investigators, contract research organizations, and institutional review boards involved in IND studies, Based on information from 1572
WHEN : Updated quarterly
WHO : CDER
WHY : Need to take action against fraudulent supplements that can cause serious risk to consumer (e.g. egregious benefit claims in treating serious diseases) or widespread economic fraud.
WHAT : Newly created; to enhance effectiveness of dietary supplement regulation
WHO : Under CFSAN, will work closely with CDER to help remove falsely labeled supplements
What: Discuss/Recommend clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology.
When: February 18, 2016
Where: Hilton Washington DC
What: Analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy
When: January 25, 2016
Where: FDA White Oak Campus
Who : Registration
NDA 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant for proposed indication of maintenance treatment of opioid dependence More information
Research updates from Division of Viral Products, CBER, FDA. More information
Details posted previously. Medical device cybersecurity More information
Latest bio-analytical methods and practical applications. More information
Summarizes FDA’s Philosophy
Ideally, IND sponsors and FDA work collaboratively during the drug development process, having a shared public health goal of early availability of safe, effective, and high-quality drugs to the American public.
WHAT : To see if particular biological product has been determined by to be biosimilar to or interchangeable with a reference biological product
WHY : User friendly resource for Biologics & Biosimilars (similar to The Orange Book for drugs & generics)
WHERE : http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm411418.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
WHAT: Discuss safety and efficacy issues, clinicians perspectives on use in real world.
WHERE : American Society of Hematology (ASH) 57Th Annual meeting and Symposium, Orlando, Florida
WHEN: December 7, 2015: 4:30 PM-6:00 PM
WHO: Panelists- FDA, Mayo Clinic, Harvard Medical School
WHAT: To discuss complex challenges in medical device cybersecurity that impact the medical device ecosystem.
WHEN, WHERE: Jan 20-21, 2016, FDA White Oak Campus , MD
WHO: FDA, National Health Information Sharing Analysis Center, Department of Health and Human Services, Department of Homeland Security
Watch this space….
Learning Objectives: Optimize FDA’s regulation of next-generation sequencing (NGS)-based in vitro diagnostic tests
Botanical Drug Review
Regulation of Botanical Drugs
OTC Drug Monograph: Establishment of standards (monographs or non-monographs) for an OTC therapeutic drug category.
IND, NDA: For human testing and marketing approval the product for the proposed use. CMC Information: Often different from that for synthetic or highly purified drugs.
Consumer Representatives serve as Special Government Employees on a committee for up to a four-year term.
Provide the perspective of consumers to advisory committees and do not represent their own personal expertise. Their role is to:
WHAT : Discuss clinical development of drugs and therapeutic biologics for osteoporosis treatment.
WHEN : November 4, 2015, 8:00 am to 5:00 pm
WHERE: FDA White Oak Campus
WHO : Contact : Osteoporosis_Workshop@fda.hhs.gov.
WHAT : Prescription Drug Labeling – Challenges and Issues
– Developing the prescribing information
– Safety considerations to minimize medication errors,
– Patient labeling (e.g., Patient Medication Information), and
– Promotional aspects of labeling.
WHEN : November 3-4, 2015, 8:00 am to 5:00 pm
WHERE: Bethesda Marriott, Pooks Hill, MD
FDA effort to make demographic data more available and transparent
Posted by the Office of Health and Constituent Affairs