2017-2018 FDA CALENDAR

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2017 FDA CALENDAR

 Newly added 


JANUARY

Jan 12: FDA Grand Rounds- Developing Regulatory Methods for Characterizing Nanomaterials in FDA-Regulated Products Describe methodology for characterizing inorganic and organic nanoparticles, using various microscopic techniques, light scattering, size-based separation methodology, elemental analysis, and mass spectrometry. INFORMATION

Jan 24: Guidance Webinar: Collection of Race and Ethnicity Data in Clinical Trials To  learn more about the guidance document. INFORMATION


FEBRUARY 

Feb 2:  Ninth Annual Sentinel Initiative Public Workshop . Duke-Margolis Center for Health Policy and FDA  forum to bring together leading experts and interested stakeholders to discuss the ongoing development of the Sentinel Initiative. INFORMATION

Feb 2: Webinar – Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types. Discuss final guidance, provide clarification on definition of medical device accessory and recommendations for classifying accessories, de novo process for  risk-based classification. INFORMATION

Feb 2: Public Workshop – Coordinated Registry Network (CRN) for Devices Used for Acute Ischemic Stroke Intervention (DAISI) Obtain stakeholders’ input on the coordination of registries for DAISI. INFORMATION

Feb 3:  Webinar – Final Rule on Postmarketing Safety Reporting (PMSR) for Combination Products. Discuss final rule.INFORMATION

Feb 7: Webinar -Collaborating with FDA: Get Involved with FDA’s MedWatch Adverse Event Reporting Program How to utilize FDA’s drug information, medication safety resources, and regulatory guidance, to improve delivery of patient care and optimize outcomes.INFORMATION

Feb 7: National Black HIV/AIDS Awareness Day Twitter Chat. FDA hosting a Twitter chat with BlackDoctor.org in recognition of National Black HIV/AIDS Awareness Day. Use to chat. INFORMATION

Feb 9: Webinar – Final Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions. Discuss final guidance document and clarify FDA’s approach to weighing benefits and risks for medical device product availability, compliance, and enforcement decisions. INFORMATION 

Feb 23: Circulatory System Devices Panel: Discuss de novo request for SENTINEL® Cerebral Protection System, a first of a kind embolic protection device to be used with transcatheter aortic valve replacement (TAVR) procedures. INFORMATION

Feb 23: Webinar – Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance. Help manufacturers and other interested stakeholders understand the information provided in this final guidance document. INFORMATION

Feb 23: Precision Cardiovascular Medicine Webinar Discuss current research on genetic misdiagnoses and cardiomyopathy and precision cardiovascular medicine for multiethnic populations INFORMATION

Feb 27-28: FDA-USP Workshop on Standards for Pharmaceutical ProductsCritical Importance of Excipients in Product Development – Why Excipients are Important Now and In the Future. INFORMATION


MARCH

Mar 1:  Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa. Public workshop on the current state and further development of animal models for serious infections caused by Acinetobacter baumanii and Pseudomonas aeruginosa. INFORMATION

Mar 6-7:  Pediatric Advisory Committee Meeting. Safety reviews for drugs – NITROPRESS, KUVAN, TRUVADA, EXJADE and devices EPICEL, IMPELLA RP SYSTEM, LIPOSORBER LA-15 SYSTEM, MEDTRONIC ACTIVA DYSTONIA THERAPY. Also discuss safety reviews for NOVOEIGHT  and RIXUBIS Coagulation Factor IX. INFORMATION

Mar 9: Vaccines and Related Biological Products Advisory Committee Meeting.  Discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017-2018 influenza season INFORMATION

Mar 13-14: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. Safety issues for OPANA ER (oxymorphone hydrochloride) NDA – pre- and post-marketing data about the abuse and the overall risk-benefit of product. INFORMATION

Mar 15: Advisory Committee Meeting for Pharmaceutical Science and Clinical Pharmacology.  Physiologically-based pharmacokinetic modeling and simulation throughout a drug’s lifecycle & mechanistic model-informed safety evaluation with a focus on arrhythmias.  INFORMATION

Mar 17:  Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee.  Potential risks of misuse of PEROXIDE-BASED CONTACT LENS PRODUCTS, adequate labeling and packaging of these over-the-counter products. INFORMATION

Mar 19-21: FDA/PhUSE Computational Science Symposium. Review progress on data standards, best-practices-driven analytical tool development, business processes that are driving development of information systems, experiences and evaluation of current tools by users themselvesINFORMATION

Mar 22: FDA Webinar Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to the De Novo Pathway . For developers and sponsors of neurological devices on the De Novo pathway, an alternate pathway to classify novel devices INFORMATION

Mar 30: Grand Rounds: Vaccine adjuvants -New ways to evaluate their safety and effectiveness.  Adjuvants and immune responses, safety concerns and appropriate studies. INFORMATION


APRIL

Apr 4-5: Blood Products Advisory Committee Meeting. Discuss Recombinant Human Coagulation Factor IX, GlycoPEGylated, responses to Blood Donor Deferral Policy for Reducing the Risk of HIV  Transmission by Blood and Blood Products, research programs in Laboratory of Emerging Pathogens, Division of Emerging Transfusion-Transmitted Diseases. INFORMATION

Apr 5: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting.  Discuss NDA for oxycodone hydrochloride immediate-release oral tablets with the proposed indication of management of moderate to severe pain where the use of an opioid analgesic is appropriate. Product formulated with properties intended to deter abuse. INFORMATION

Apr 6: Public Workshop: Emerging Tick-Borne Diseases and Blood Safety. Discuss tick-borne pathogens, effectiveness of mitigation strategies, blood safety interventions.INFORMATION

Apr 6: Public Meeting: Patient-Focused Drug Development Meeting for Sarcopenia. Perspectives of patients with sarcopenia on i) symptoms and the daily impacts of their condition ii) current approaches to treatment, and iii) decision factors taken into account when selecting a treatment.INFORMATION

Apr 12-13: Antibody Mediated Rejection (AMR) in Kidney Transplantation Workshop. Regarding new developments and scientific issues related to antibody mediated rejection (AMR) in kidney transplantation. INFORMATION

Apr 13: FDA CERSI Lecture on Zika Virus Vaccines and Therapeutics. Dr. Monica McArthur, MD. PhD.  will discuss the anti-Zika virus vaccine candidates now in the pipeline and efforts to identify effective therapeutics.  INFORMATION

Apr 19-20: Public Workshop: Battery Safety Concerns in Electronic Nicotine Delivery Systems. Hazards and risks associated with use of batteries in ENDS, including e-cigarettes. INFORMATION

Apr 24: International Council for Harmonization Regional Public Consultation. Co-hosting with Health Canada to solicit public input prior to next ICH meeting. Topics relate to harmonization of various manufacturing guidelines. INFORMATION

Apr 24-26: 11th Annual FDA/DIA Statistics Forum. Discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. INFORMATION

Apr 25; FDA/C-Path PRO Consortium: Second Annual Workshop on Clinical Outcome Assessments (COAs) in Cancer Clinical Trials. Engage with leaders in academia, industry, international regulatory and health technology assessment (HTA) bodies, and patient groups to thoughtfully discuss how to integrate PRO measures and other COAs into cancer clinical trials.INFORMATION


MAY

May 3:  FY 2017 Generic Drug Research Public Workshop. Obtain input from industry and other interested stakeholders on regulatory science priorities. INFORMATION

May 3-5: FDA/Xavier University Medical Device Conference (MedCon). Public conference includes presentations from FDA officials, industry experts.  INFORMATION

May 4: Patient-Focused Drug Development for Autism. Gather patients’ perspectives on symptoms and daily impacts and discuss current treatment optionsINFORMATION

May 4: Reagan Udall Foundation for the FDA Public Meeting.  To receive public input on Foundation’s efforts to  catalyze programs and projects by bringing together FDA, patient/consumer groups, academia, other government entities, and industry to work together transparently in developing cutting edge regulatory scienceINFORMATION

May 8-9:  Meeting of the Pharmacy Compounding Advisory Committee Meeting. Discuss quality standards and conditions at certain compounding facilities. INFORMATION

May 9-10: Regulatory Education for Industry (REdI) Spring Conference. Conference Topics include: CDER: Types of INDs; Chemistry, Manufacturing and Controls (CMC); Pharmacology/Toxicology; Drug Inspections CDRH: 510(k); Biocompatibility in Premarket Submissions; Nonconforming Product; Device Inspections. INFORMATION

May 9-10: Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics – Exploring the Path Forward. Public meeting on issues and challenges with Federal efforts to support training on pain management and the safe prescribing, dispensing, and patient use of opioids.  INFORMATION

May 10: Meeting of the Medical Imaging Drugs Advisory Committee. Discuss NDA for 5-Aminolevulinic Acid Hydrochloride [5-ALA HCl], Powder, for oral solution, for the proposed indication as an imaging agent to facilitate the real time detection and visualization of malignant tissue during glioma surgery. INFORMATION

May 11: FDA Grand Rounds. FDA Research: an Alternative Approach to Presenting Risk Information in Prescription Drug TV Ads. Discuss “major statement” in direct-to-consumer TV ads INFORMATION

May 12: Roadmap for Engaging With the FDA/CDER. Public Workshop for patient advocacy groups. Enhance understanding of approval of safe and effective drug therapies for patient advocacy.  INFORMATION

May 17: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting. Discuss PMA for TRANSMEDICS ORGAN CARE SYSTEM (OCS)–Lung System, by TransMedics, Inc.  The proposed Indication for Use -Portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, perfused state for transplantation  INFORMATION

May 18-19: Public Workshop – Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis. Examine opportunities for FDA engagement with new and ongoing research, catalyze collaboration among Health Care and Public Health stakeholders to strengthen medical device cybersecurity. INFORMATION

May 24: Meeting of the Oncologic Drugs Advisory Committee. Discuss  NDA for neratinib maleate, for proposed indication for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant traustuzumab-based therapy (morning session). Discuss NDA for L-glutamine powder (oral solution), for the proposed indication of treatment of sickle cell disease (afternoon session) INFORMATION

May 25: Meeting of the Oncologic Drugs Advisory CommitteeDiscuss BLA  for  proposed biosimilar to Epogen/Procrit (epoetin alfa) INFORMATION

May 31-Jun 1: 2017 FDA Science Forum. Highlight breadth and depth of cutting-edge science FDA conducts and demonstrate how FDA’s scientific research informs regulatory decision-making. INFORMATION


 JUNE

Jun 6: DDI Webinar Series: Ongoing Role of FDA in Medication Error Prevention. Information on the Division of Medication Error Prevention and Analysis (DMEPA)’s role in preventing and addressing medication errors, as well as the role of pharmacists in identifying, preventing and mitigating medication errors. INFORMATION

Jun 15: Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive.  Purpose, Process, and Challenges and Structured Product Labeling Format. INFORMATION

Jun 15: Safe Use Symposium: A Focus on Reducing Preventable Harm from Drugs in the Outpatient Setting. Discuss sources of preventable harm from drugs in outpatient setting, interventions to reduce preventable harms and how these interventions can be studiedINFORMATION

 Jun 19: The Ins and Outs of Presenting Clinical Pharmacology Information in Prescription Drug Labeling. Highlights from the FDA guidance, Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format, and key prescription drug labeling regulations. INFORMATION

Jun 20: Endocrinologic and Metabolic Drugs Advisory Committee Meeting.  Discuss sNDA for VICTOZA (liraglutide) injection (sNDA 022341), for proposed additional indication to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and high cardiovascular risk. INFORMATION

Jun 21-22: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting  Gauge investigator interest in potential pediatric development plans for several products in various stages of development for adult cancer indications. INFORMATION


JULY

Jul 10: Public Workshop – Sentinel Training at the Food and Drug. Provide training on using health care claims data within the FDA Sentinel System and understanding of system capabilities INFORMATION  

Jul 11: Oncology Drugs Advisory Committee Meeting. Discuss BLA for MYLOTARG for proposed indication (use) as combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of adult patients with previously untreated, de novo acute myeloid leukemia (AML). INFORMATION

Jul 12: Oncology Drugs Advisory Committee Meeting.  Discuss BLA for tisagenlecleucel-T suspension for proposed indication (use) for treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). INFORMATION

 Jul 13: Oncology Drugs Advisory Committee Meeting.  Discuss BLA for ABP 215, a proposed biosimilar to Genentech/Roche’s AVASTIN (bevacizumab) and BLA for MYL-1401O, a proposed biosimilar to Genentech Inc.’s HERCEPTIN. INFORMATION

Jul 13: Optimizing Your Study Data Submissions to FDA – Updates from CDER and CBER. Recent updates Study Data Technical Conformance Guide and recommendations to optimize your study data submission to improve efficiency of review process and avoid technical rejection. INFORMATION

Jul 17: Public Workshop: Developing Rabies Monoclonal Antibody Products as a Component of Rabies Post-Exposure Prophylaxis. Provide information for, and gain perspective from stakeholders on various aspects of development efforts pertaining to animal models, laboratory assays, and clinical trials. INFORMATION

 Jul 18: Public Meeting: Administering the Hatch-Waxman Amendments. Ensuring a Balance Between Innovation and Access. Submit comments on Federal Food, Drug, and Cosmetic Act (FD&C Act) to balance drug innovation and accelerating availability to lower cost alternatives. INFORMATION

 Jul 19: Public Workshop: Development of New Tuberculosis Treatment Regimens-Scientific and Clinical Trial Design Considerations. Provide information for and gain perspective from stakeholders regarding scientific and clinical trial design considerations related to the development of new TB regimens. INFORMATION

Jul 20: FDA/MDIC Forum on Case for Quality. The CDRH Case for Quality team will lead a discussion on ongoing preparations for the proposed third party voluntary quality programINFORMATION

Jul 26:  Webinar- Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Premarket Approvals. Overview of PMA process, non-clinical testing,  manufacturing, post-approval studies for neurological devices.  INFORMATION

 Jul 28: Biological Advisory Committee Meeting Discuss safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax. INFORMATION

AUGUST

Aug 1:  Digital Health Software Precertification (PreCert) Pilot Program. Discuss and answer questions about this precertification pilot program.   INFORMATION

Aug 2:  Arthritis Advisory Committee Meeting. Discuss BLA for PLIVENSIA (sirukumab) injection for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs. INFORMATION

Aug 3:  Arthritis Advisory Committee Meeting. Discuss sNDA for XELJANZ (tofacitinib) and for XELJANZ XR extended release tablets for the treatment of adult patients with active psoriatic arthritis. INFORMATION

Aug 24:  Webinar – CDRH Final Guidance: Qualification of Medical Device Development ToolsMDDT program is a voluntary process intended to reduce regulatory burden for tool developers and FDA reviewers through the qualification of tools that can aid in the development and evaluation of medical devices. INFORMATION

Aug 31: FDA/CDRH – RSNA SIG Joint Meeting on 3D Printed Patient-specific Anatomic Models. FDA-CDRHand Radiological Society of North America 3D printing Special Interest Group (RSNA SIG) to discuss clinical use of 3D printed patient-specific anatomic models. INFORMATION


SEPTEMBER

Sep 8:  Pediatric Trial Design and Modeling: Moving into the next decade. Review current best practices in designing trials, discuss problems and potential solutions, optimize trials to achieve labeling. INFORMATION

Sep 8: Meeting of the Medical Imaging Drugs Advisory Committee. Discuss the potential risk of gadolinium retention in the brain and other body organs in patients receiving gadolinium-based contrast agents for magnetic resonance clinical imaging procedures. INFORMATION

Sep 11: Patient-Focused Drug Development Public Meeting for Alopecia Areata. To obtain patient input on the impact of alopecia areata, including on daily life, patient views on treatment approaches, and decision factors taken into account when selecting a treatment. INFORMATION

Sep 12: Public Workshop: Reducing the Risk of Preventable Adverse Drug Events associated with Hypoglycemia in the Older Population Discuss importance of individualized glycemic control targets for older patients with diabetes. INFORMATION

Sep 13: Public Workshop – Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices. Discuss scientific and regulatory challenges of development of traditional devices for antimicrobial susceptibility testing (AST), novel diagnostic technologies for detection of antimicrobial resistance markers, and new regulatory solutions per 21st Century Cures Act. INFORMATION

Sep 13: Vaccines and Related Biological Products Advisory Committee Meeting Announcement. Discuss safety and effectiveness of Zoster Vaccine Recombinant (Adjuvanted) [Shingrix], manufactured by GlaxoSmithKline. INFORMATION

Sep 14: FDA Grand Rounds- Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs. A new model, the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative, aims to be a more accurate and comprehensive, mechanistic-based assessment of drug safety. INFORMATION

Sep 14: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Discuss sNDA for BUTRANS (buprenorphine) transdermal system in pediatric patients ages 7 through 16 years for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. INFORMATION

Sep 15: FDA-ASCO: Hematology and Oncology Fellows Day Workshop. Provide current hematology and oncology fellows with a solid foundation in the process of oncology drug development and regulatory science. INFORMATION

Sep 18: Public Workshop on Benefit-Risk Assessments in Drug Regulatory Decision-Making. Discuss structured assessment of benefits and risks in drug regulatory decision-making, incorporating patient perspectives, methods to advance structured benefit-risk assessment. INFORMATION

Sep 18-19: Public Workshop- Advancing the Development of Pediatric Therapeutics (ADEPT): Application of “Big Data” to Pediatric Safety Studies. To understand (1) how to access and analyze “Big Data” associated with safety information in the healthcare setting and (2) utility and challenges associated with the use of “Big Data” to study the safety of therapeutics in children. INFORMATION

Sep 18-20: FDA-Agência Nacional de Vigilância Sanitária (ANVISA), Brazil Health Authority, Global Summit on Regulatory Science Emerging Technologies for Drug and Food Safety. Held at ANVISA Brasilia, DF BRAZIL. INFORMATION

Sep 19:  Meeting of the Oncologic Drugs Advisory Committee. Discuss sNDA for SUTENT (sunitinib malate) oral capsules for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy. INFORMATION

Sep 19: Webinar – Enhancements to CDRH Export Certification and Tracking System (CECATS). Highlight enhancements to  CECATS, a web-based, voluntary electronic system for requesting export documents for international tradeINFORMATION

Sep 21: Yale-CERSI Webinar.“Real World” Evidence: Beyond Randomized Controlled Trial. Concept of real world evidence, policy implications, available approaches and frameworks, observational evidence. INFORMATION

Sep 25: Primary Pediatric Hypertension Workshop: Epidemiology and Treatment Gaps. To discuss the current state of hypertension epidemiology, pathophysiology,  diagnosis, and treatment in the pediatric population. INFORMATION

Sep 27: Public Meeting on Patients Who Have Received an Organ Transplant. To obtain patient input on the impact of receiving an organ transplant on daily life and patients’ views on currently available therapies to manage organ transplantation.  INFORMATION

Sep 27-28: FDA Small Business Regulatory Education for Industry (REdI): Fall Conference. Provide direct, relevant, and helpful information on the key aspects of drug and device regulations. INFORMATION

Sep 28: Peripheral and Central Nervous System Drugs Advisory Committee. Discuss NDA for ataluren for oral suspension, sponsored by PTC Therapeutics, Inc., for the treatment of patients with dystrophinopathy due to a nonsense mutation in the dystrophin gene. INFORMATION


OCTOBER

Oct 2-3: Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review. Discuss current and emerging scientific approaches and applications for quantitative modeling and simulations in generic drug development. INFORMATION

Oct 5: Electronic Drug Registration and Listing Using CDER Direct  INFORMATION

Oct 6: Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing. Discuss use of in vitro testing to demonstrate bioequivalence of complex generic drugs.  INFORMATION

Oct 10:  Voluntary Medical Device Manufacturing and Product Quality Program.  Announce the proposed framework and preliminary outline of a voluntary pilot program that recognizes an independent assessment of manufacturing and product quality.  INFORMATION

Oct 10: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. Overview of real-world data and real-world evidence and FDA evaluation of dataINFORMATION

Oct 11, 12: Inaugural meeting of Patient Engagement Advisory Committee (PEAC).  Provide advice and recommendations to FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. INFORMATION

Oct 12: Biologics Advisory Committee Meeting: Cellular, Tissue, and Gene Therapies:  Discuss BLA for voretigene neparvovec, submitted by Spark Therapeutics, for treatment of vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy.

Oct 17:  An Overview of FDA Resources. Resources to respond to questions, and to promote safe use of drug products. Topics will include drug shortages, recalls, adverse events, and safety labeling updatesINFORMATION

Oct 19: Health Canada and FDA Joint Public Consultation on ICH Technical Requirements for Pharmaceuticals for Human Use. Solicit public input prior to the next ICH Assembly meeting and the expert working groups meetings in Geneva, Switzerland. INFORMATION

Oct 20: Overcoming Barriers to Product Development, Regulatory Approval and Commercialization of Affordable, High Quality, Generic Topical Dermatological Drug Products. Discuss current barriers in development of topical dermatological generic drug products and ways to improve patient accessINFORMATION

Oct 26:  Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices Final Guidance. Discuss Agency’s recommendations for developing safe and effective devices that exchange and use patient information  electronically. INFORMATION

Oct 30: CDER Rare Diseases Public Workshop: Strategies, Tools and Best Practices for Effective Advocacy in Rare Diseases Drug Development.Primarily for rare disease community members to help understand FDA’s needs, case studies on beneficial overlap of effective advocacy techniques and FDA regulations.  INFORMATION

Oct 31: Webinar – Final Guidance on “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” Recommendations to improve the quality, consistency and transparency of data on how medical devices perform within specific age, race, and ethnic groups. Proper evaluation and reporting of this data can benefit patients, clinicians, researchers and regulators INFORMATION


NOVEMBER

Nov 1: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Discuss new drug application (NDA) 210136, buprenorphine subcutaneous injection, submitted by Braeburn Pharmaceuticals, Inc., for treatment of opioid dependence. INFORMATION

Nov 6:  Public Workshop: Geriatric Oncology by FDA and the American Society of Clinical Oncology (ASCO) Discuss improving the evidence base for treating the geriatric oncology population.  INFORMATION

Nov 6-7: National Center for Toxicological Research Science Advisory Board Meeting. Center-wide update on scientific initiatives and accomplishments, discuss  research strategic needs and potential areas collaboration.  INFORMATION

Nov 7: Vaccines and Related Biological Products Advisory Committee Meeting
Discuss clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations. INFORMATION

Nov 7:Industry Basics Workshop – Nonconforming Product and Complaint Files Presentation and Q/A session with Office of Compliance and Office of Communication and Education INFORMATION

Nov 9: FDA Grand Rounds: Assessing the safety and effectiveness of new and emerging therapeutic ultrasound technologies. Research into therapeutic ultrasound’s bioeffects, many of which remain poorly understood. INFORMATION

Nov 8-9: Immune Globulin Potency in the 21st Century. Public workshop to discuss new challenges to meet U.S. potency requirements for Immune Globulin (IG) products and to identify measures to address challenges.  INFORMATION

Nov 13: Partners in Progress: Cancer Patient Advocates and FDA. Provide basic training on the role of the FDA and cancer patient advocates in oncology product development. Supported by American Association for Cancer Research (AACR), American Society of Clinical Oncology (ASCO), and American Society of Hematology (ASH).INFORMATION

Nov 15-16: FDA Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice. Co-sponsored with Society of Clinical Research Associates (SOCRA).to aid the clinical research professional’s understanding of the mission and authority of FDA and to facilitate interaction with FDA representatives. INFORMATION

Nov 16: Devices Referencing Drugs; Public Hearing. Potential approach for certain device sponsors to seek marketing authorization for a device labeled for use with a drug that is already approved and on the market, when the drug sponsor does not wish to pursue the new use. Called devices referencing drugs (DRDs), these products have the potential to advance public health by offering new uses with approved, marketed drugs that might not otherwise be availableINFORMATION 

NOV 16: Antimicrobial Drugs Advisory Committee.Discuss NDA for ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients with respiratory bacterial pathogensINFORMATION

Nov 16:  Webinar on Final Guidances on “Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”.  For medical device changes and software-specific changes INFORMATION

Nov 17: Webinar – PreCertification (Pre-Cert) Pilot Update First in series on Digital Health PreCertification (Pre-Cert) Pilot Program; keep efforts transparent, share updates throughout pilot process INFORMATION

Nov 21: Webinar – De Novo Classification Process (Evaluation of Automatic Class III Designation) Provide updated recommendations for interacting with the FDA, including what information to submit when seeking a path to market via the De Novo classification process. INFORMATION

Nov 28: Public Workshop – Cardiac Troponin Assays. Discuss development of innovative troponin assays designed to aid in the diagnosis of Myocardial Infarction (MI) and additional clinical uses of these assays. INFORMATION

Nov 28FDA-NCI Public Workshop: Defining Disease Recurrence and Harmonizing Conduct in Adjuvant Bladder and Kidney Cancer Trials. Joint FDA, NCI, and  Society of Urologic Oncology (SUO) workshop to improve conduct of adjuvant clinical trials in bladder cancer and kidney cancer by harmonizing definitions and management of disease recurrence.  INFORMATION

Nov 30:  Webinar – Unique Device Identification: Direct Marking of Devices Final Guidance. Discuss direct marking requirements including how FDA interprets the term “intended to be reprocessed,” further explaining other aspects of UDI direct marking. INFORMATION


DECEMBER

Dec 5:  DDI Webinar Series: Biosimilars. Educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians INFORMATION

Dec 7: Advisory Committee Meeting: Bone, Reproductive and Urologic Discuss appropriate patient selection criteria and clinical trial design features, for drugs intended to treat interstitial cystitis and bladder pain syndrome. INFORMATION

Dec 11-12: Packaging, Storage, and Disposal Options to Enhance Opioid Safety-Exploring the Path Forward. Role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioids INFORMATION

Dec 12: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting. Discuss PMA for Barricaid Anular Closure Device by Intrinsic Therapeutics, intended to be implanted following a limited discectomy, to prevent reherniation and the recurrence of pain or dysfunction INFORMATION

Dec 15: Public Workshop: Medical Gas Regulation.  Opportunity for medical gas
manufacturers to provide input on potential areas of Federal drug regulation that should be revised with respect to medical gases.  INFORMATION

Dec 18: Public Workshop: Patient-Focused Drug Development – Guidance 1, Collecting Comprehensive and Representative Input. Discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA to inform regulatory decision-making may use. INFORMATION

Dec 18: Webinar – Regulatory Overview for Developers and Sponsors of Neurological Devices. An Introduction to Humanitarian Device Exemptions (HDEs).  Overview of HDE regulatory pathway, and humanitarian use devices (HUDs) INFORMATION


2018

⊗ Jan 8: CLIA Waiver Applications Draft Guidance Documents. Discuss draft guidances on CLIA waiver applications and Dual 510(k) and CLIA waivers INFORMATION

Jan 11: Public Workshop – Self-Collection Devices for Pap Test. Obtain feedback on feasibility, benefits, risks for self-collection cervical sampling devices for cervical cancer screening by Pap testing INFORMATION

⊗ Jan 11:  Safety Assessment for IND Safety Reporting. Convened by the Duke-Robert J. Margolis Center for Health Policy at Duke University and FDA; to bring stakeholder community together to discuss IND safety topics INFORMATION

 Jan 29: Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology. To discuss how genetic sequencing data is best implemented in patient management to advance innovative regulatory strategies to support development of safe and effective precision-based drugs and devices. INFORMATION

 Jan 30-31: Fostering Digital Health Innovation. Developing the Software Precertification Program. Discuss progress of pilot precertification program and seek input on ongoing development of the Software Precertification Program. INFORMATION

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