2018 FDA CALENDAR

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AUGUST

Aug 13-14: Public Meeting – Pediatric Medical Device Development. Identify strategies that enhance medical device ecosystem toward development and innovation of devices that serve the complex needs of children. INFORMATION


JULY

Jul 9:  Public Meeting for Patient Focused Drug Development for Chronic Pain. Hearing patients’ perspectives on chronic pain, treatment approaches, challenges or barriers to accessing treatments and managed with opioids, acetaminophen, NSAIDs, antidepressants, non-pharmacologic interventions or therapies.INFORMATION


JUNE

Jun 19-20: FDA/IMSN Summit with international drug regulators to discuss medication safety issues. Discussion among international drug regulators on medication safety issues with regulated pharmaceutical products and how to minimize medication errors with labeling and packaging. INFORMATION

Jun 22: Clinical Outcome Assessments (COAs) in Cancer Clinical Trials. Discussion between academia, industry, international regulatory, HTA bodies, and patient groups to advance measurement of the patient experience in cancer clinical trials; characteristics of PRO measurement tools, standardize PRO data analysis, FDA approaches to PRO data review. INFORMATION

Jun 25-26: 2018 Center for Biologics Evaluation and Research Science Symposium. Discuss scientific topics related to the regulation of biologics and highlight science conducted at CBER by showcasing how scientific research informs regulatory decision making and to provide a forum for developing collaborations within FDA and with external organizations.


MAY

May 2: Antimicrobial Drugs Advisory Committee Meeting. Discuss NDA for plazomicin, sponsored by Achaogen for proposed indications for treatment of complicated urinary tract infections & blood stream infections in adults  INFORMATION

May 3: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee Meeting. Discuss NDA for stannsoporfin injection, submitted by InfaCare, proposed for treatment of neonates with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia INFORMATION

May 4: Annual Public Meeting; Reagan-Udall Foundation for the FDA. FDA Commissioner Scott Gottlieb as keynote speaker; discuss activities and how it supports FDA; panel discussion on “Evolution of FDA Science and Engagement.” INFORMATION

 ⊕ May 8: FDA Drug Topics: Protecting Patients – Pharmacists Requirements under the Drug Supply Chain Security Act. FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is presenting a series of continuing education webinars targeting the needs of all health care professionals. INFORMATION

May 8: CBER Update: Office of Vaccine Research and Review Data Submission. Update on best practices INFORMATION

May 9: Tissue Agnostic Therapies: Regulatory Considerations for Orphan Drug Designation; Public Workshop. Discuss factors when evaluating drugs for orphan designation that treat tissue agnostic disease or condition in oncology, additional factors related to orphan exclusivity when approving such a product INFORMATION

⊕ May 10: User Session – Digital Health Software Precertification (Pre-Cert) Pilot Program. Interactive session to discuss progress on Software Precertification Pilot Program, working model, key program areas, questions for public input.  INFORMATION

May 10: FDA Grand Rounds spotlights stakeholder opportunities in FDA predictive toxicology roadmap. Framework for integrating novel predictive toxicology methods into safety and risk assessments of its products. INFORMATION

May 10: Endocrinologic and Metabolic Drugs Advisory Committee Meeting. Discuss NDA for volanesoren solution for subcutaneous injection, Akcea Therapeutics, Inc, for use as an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome. INFORMATION

May 11: Medical Gas Workshop III. Provide opportunity for medical gas manufacturers and public to provide input on potential areas of Federal drug regulation that should be revised with respect to medical gases.  INFORMATION

May 15-16: FDA Regulatory Education for Industry (REdI). FDA-led forum that brings together the regulatory educators from FDA’s CDER and CDRH. Meeting Information

May 17:  Webinar: Pioneering Modeling Methodologies in Generic Drug Development. Discuss novel ways FDA is approaching the use of quantitative methods and modeling for development and demonstration of generic samenessINFORMATION 

May 18: MDIC workshop on Patient-Centered Clinical Trial Design. Method for incorporating patient preference information to set significance levels in clinical trial design. Focus on Parkinson’s disease; may be generalizable to other diseases.  In collaboratorion with FDA (CDRH), MIT, RTI Health Solutions and Michael J. Fox Foundation. INFORMATION

May 22: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee.  Discuss NDA for buprenorphine sublingual spray, by INSYS, for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate INFORMATION

May 22-23: Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to Food and Drug Administration-Recognized Standards; Public Workshop.  Discuss draft design of pilot program, including goals and scope, framework, requirements, and streamline standards. INFORMATION

May 24: FY 2018 Generic Drug Research Public Workshop.  Provide overview of regulatory science initiatives for generic drugs and public input on research priorities INFORMATION


APRIL

Apr 3: Public workshop: CDER and You: Keys to Effective Engagement. Share information with stakeholders including patients, patient advocates, academic and medical researchers, health care professionals, drug developers. Share unique perspectives on drug development and safety. INFORMATION

Apr 6: US FDA and Health Canada: Joint Regional Consultation on the ICH. To provide information and receive comments on the current ICH activities as well as the upcoming meetings in Kobe, Japan INFORMATION

Apr 10: FDA Drug Topics: An Introduction to Drug Safety Surveillance and the FDA Adverse Event Reporting System. Introduce the many phases of drug safety surveillance from the earliest stages of drug development through post approval, and will focus on how FDA conducts pharmacovigilance, develops safety signals, and communicates our findings.INFORMATION

Apr 11-12: CDER Small Business and Industry Assistance Regulatory Education for Industry (REdI): Generic Drugs ForumInteract with FDA subject matter experts  on Generic Drug Review Program, program progress, current initiatives. INFORMATION

Apr 16: Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Public Meeting. Discuss topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population. INFORMATION

Apr 16: Public Workshop: Study Design Considerations for Devices including Digital Health Technologies for Sleep Disordered Breathing (SDB). Appropriate design of clinical studies to evaluate devices including digital health technologies intended for the diagnosis, monitoring, or treatment of SDB INFORMATION

Apr 16-18: 2018 AAPS Workshop on Drug Transporters in ADME: From Bench to Bedside. Present next generation of transporters and transport mechanisms that may contribute to ADME properties of drugs in disease states considered in drug discovery and development. INFORMATION 

Apr 17: Public Meeting on Patient-Focused Drug Development for Opioid Use Disorder (OUD). To learn patients’ perspectives on OUD, effects on health and well-being, experience using prescription medical treatments and other treatments, challenges or barriers to accessing medical treatments for OUD. INFORMATION

Apr 19: Peripheral and Central Nervous System Drugs Advisory Committee Meeting Discuss NDA for cannabidiol oral solution, GW Pharmaceuticals, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. INFORMATION

Apr 20: FDA/OCE Public Meeting on Relevant Molecular Targets in Pediatric Cancers: Applicability to Therapeutic Investigation FDARA 2017. Discuss provisional list of molecular targets for adult cancer indications but also relevant to cancer in children thereby providing a rationale for early pediatric evaluation. INFORMATION

Apr 21: Public Meeting on Electronic Submissions and Data Standards. Discuss current status of electronic submissions and data standards initiatives to improve predictability and consistency of electronic submissions process in support of human drug review program. INFORMATION

Apr 23: Arthritis Advisory Committee Meeting. Discuss NDA for baricitinib tablets, submitted by Eli Lilly and Company, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. INFORMATION

Apr 23-25: 12th Annual FDA/DIA Biostatistics Industry and Regulator Forum. Discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. INFORMATION

Apr 30Public Workshop – Orthopaedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices. Enhance engagement with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with Orthopaedic SMART Devices.   INFORMATION


MARCH

Mar 1: Vaccines and Related Biological Products Advisory Committee Meeting. Hear  research program in the Laboratory of Mucosal Pathogens and Cellular Immunology (LMPCI), Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), and discuss selection of strains to for vaccines for the 2018-2019 influenza season INFORMATION

Mar 1: 21st US-Japan Cellular and Gene Therapy Conference. Exchange ideas on cutting edge and diverse areas of biomedical research, and enhance opportunities for collaborations among scientists from the US and Japan.  INFORMATION

Mar 1: Neurological Devices Panel  Advisory Committee Meeting. Discuss safety and effectiveness of intracranial aneurysm treatment devices and factors affecting clinical outcomes such as aneurysm morphology, size, and location in the neurovasculature. INFORMATION

Mar 1-2: IASLC-FDA Lung Cancer Neoadjuvant Meeting.Discuss standardization and validation of endpoints in neoadjuvant lung cancer trials. INFORMATION

Mar 4-6: FDA-PhUSE Computational Science Symposium. Review progress on topics such as data standards, best-practices-driven analytical tool development, business processes for information systems, evaluation of current tools. INFORMATION

Mar 5: Risk Communication Advisory Committee Meeting. Committee will discuss  impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule.  INFORMATION

Mar 8: FDA Grand Rounds:  Stem cell-based cellular therapies. Use of stem cell-based products is new and characterizing the product still faces hurdles.  FDA conducting research into identifying cell therapy product characteristics that will predict the reliably of the performance of cell-based therapies in humans. INFORMATION

 Mar 8: Gastrointestinal Drugs Advisory Committee Meeting. Discuss sNDA for XELJANZ (tofacitinib) proposed for the treatment of adult patients with moderately to severely active ulcerative colitis. INFORMATION

Mar 8: Public Workshop: Safety Assessment for Investigational New Drug Safety Reporting. Engage external stakeholders in discussions related to finalizing the draft guidance entitled “Safety Assessment for IND Safety Reporting.” INFORMATION

Mar 15: Oncology Center of Excellence Listening Session; Solicit comments regarding what stakeholders desire of the OCE in terms of structure, function, regulatory purview, and activity. INFORMATION

Mar 20: Promoting the Use of Complex Innovative Designs (CID) in Clinical Trials. March 20, 2018. Discuss use of CID in drug development and regulatory decision making, CID pilot program. INFORMATION

Mar 21-22: Joint Meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel. Discuss reclassification from Class III to Class II of nucleic acid and serology-based point-of-care and laboratory-based in vitro diagnostic devices indicated for use as aids in the diagnosis of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infection.⊕ INFORMATION

Mar 22: Webinar – Duodenoscope Sampling and Culturing. FDA, CDC, ASM and other endoscope culturing experts will review the voluntary duodenoscope surveillance sampling and culturing protocols to monitor quality of reprocessing procedures.  INFORMATION

Mar 22:  Patient Engagement in the National Evaluation System for health Technology (NEST): Lessons Learned and Best Practices Workshop.  Gather lessons learned and best practices for patient engagement in evidence generation (planning, collection of data and information, analysis, and dissemination). INFORMATION

Mar 22: Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee Meeting. To discuss major objectives of Phase 3 drug development program for treatment of children with achondroplasia (ACH) submitted by BioMarin Pharmaceutical Inc. INFORMATION

Mar 23: Advisory Committee Meeting: Pediatric. Discuss the following products for CDER – BANZEL, INTUNIV, LEXAPRO and CDRH – FLOURISH, ACTIVA, LIPOSORBER, IMPELLA RP SYSTEM. INFORMATION

Mar 26-28: Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics for Alcoholic Hepatitis and Alcohol Associated Liver Disease and Pediatric Irritable Bowel Syndrome and Pediatric Functional Constipation Workshop, Facilitate dialogue among industry, academia, and other stakeholders on common data elements needed to be included in clinical trials, clinical trial designs, potential surrogate and clinical benefit endpoints, and practical issues with managing clinical trials.  INFORMATION

Mar 27: Meeting of the Psychopharmacologic Drugs Advisory Committee. Discuss  NDA for  lofexidine hydrochloride, US WorldMeds, LLC, for mitigation of symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation treatment. INFORMATION

Mar 28: Promoting the Use of Complex Innovative Designs in Clinical Trials
Inform development of guidance document and CID pilot program. INFORMATION


FEBRUARY

Feb 1: FDA-ISoP Public Workshop: Model Informed Drug Development (MIDD) for Oncology Products. Discuss integrating human pharmacokinetic, pharmacodynamic, efficacy, safety data into models, use of  novel imaging techniques, diagnostic, predictive biomarkers, shift from traditional endpoints,  regulatory implications.  INFORMATION

Feb 7-8: 10th Annual Sentinel Initiative Public Workshop.  Bring stakeholder community together to discuss a variety of topics on active medical product surveillance. INFORMATION

Feb 14-15:  Joint Drugs Advisory Committee Meeting: Anesthetic and Analgesic Products and Drug Safety and Risk Management. Discuss NDA for HYDEXOR, for the short-term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting. Also discuss sNDA  for EXPAREL (bupivacaine liposomal injectable suspension) to produce local analgesia and as a nerve block to produce regional analgesia. INFORMATION

Feb 22-23: FDA-AACR-ASTRO Regulatory Science and Policy Workshop – Clinical Development of Drug-radiotherapy Combinations. Address the lack of drug development for products intended specifically for use with radiation therapy.   INFORMATION

Feb 27:  Webinar – Custom Device Annual Reporting. Custom Device Exemption allows manufacturers to market medical devices designed to treat a unique pathology or physiological condition without premarket approval. Webinar to discuss custom device annual report requirement. INFORMATION

Feb 28: Public Meeting: Enhanced Drug Distribution Security under the Drug Supply Chain Security Act.Provide members of the drug distribution supply chain and other interested stakeholders an opportunity to discuss strategies and issues related to the enhanced drug distribution security provisions of the Act. INFORMATION


JANUARY

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

Jan 9:  Webinar – Pediatric Information for X-ray Imaging Device Premarket Notifications:  Discuss final guidance on radiation safety of pediatric populations in the design of X-ray imaging devices. INFORMATION

Jan 10:  Webinar – Technical Considerations for Additive Manufactured Medical Devices. Technical aspects associated with AM processes, recommendations for device design, manufacturing, testing considerations. 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 11: FDA Grand Rounds. Marker of brain injury increased in African Americans with Alzheimer’sBetter understanding of ethnicity and gender differences involved in the cause and progression of Alzheimer’s Disease could contribute to better drugs–and other types of interventions–to slow Alzheimer’s progression INFORMATION

Jan 16:  Webinar – FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions. Discuss final guidance on FDA categorization of IDE devices that is used by CMS to determine whether an IDE device, and certain related services, may be covered by CMS. INFORMATION

Jan 26: Evaluating Nicotine Replacement Therapies. Public comments on FDA’s approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including how they should be used and labeled. 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: Opioid Policy Steering CommitteePrescribing Information  Receive stakeholder input on how FDA REMS authority, might improve the safe use of opioid analgesics by curbing over-prescribing to decrease the occurrence of new addictions and limit misuse and abuse 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


Image credit: FDA

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