FDA CALENDAR, 2016 | Drug and Device Digest



FDA mtgs


Jan 21: Allergenic Products Advisory Committee Meeting 

Discuss safety and effectiveness data  for licensure of food allergy immunotherapy products, clinical development of aeroallergen immunotherapy products for prevention of respiratory allergic disease


Jan 21 : Webinar for industry – PMA Requirements Concerning Gowns Intended for Use in Health Care Settings

Review guidance document, help manufacturers and other interested stakeholders understand the information provided in this final guidance document.


Jan 21-22 : Public Workshop – Moving Forward: Collaborative Approaches to Medical Device Cybersecurity

Highlight past collaborative efforts, increase awareness of existing maturity models which are used to evaluate cybersecurity status, standards, and tools in development, and to engage the multi-stakeholder community in focused discussions on unresolved gaps and challenges that have hampered progress in advancing medical device cybersecurity


Jan 22: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting POSTPONED  due to anticipated inclement weather      

Discuss NDA for eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.


Jan 25 : Public Workshop – Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy

Discuss and receive input from stakeholders regarding approaches to the 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 in addition to describing the FDA’s process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices.


Jan 26 : CASSS Symposium – Interface of Regulatory and Analytical Sciences for Biotechnology Health Products 

Discuss latest bio-analytical methods and their practical application to biotechnological pharmaceuticals (BPs) and other health-related products, and soliciting feedback from industry, academia, government, and other stakeholders on advancements in bio-analytical methods and their application to BPs.



Feb 1 : CDER SBIA Webinar – Draft Guidance for Industry on Safety Assessment for IND Safety Reporting

Provide recommendations for identification and evaluation of important safety information. Discuss draft guidance.

Featured speaker : Robert Temple, M.D., Deputy Center Director for Clinical Science, CDER


Feb 3 : Eighth Annual Sentinel Initiative Public Workshop 

Convened by Center for Health Policy at the Brookings Institution.  Dr. Janet Woodcock, Director of CDER, FDA, will provide morning keynote address.  To discuss update on the state of FDA’s Sentinel Initiative, future of the Sentinel System and opportunities to expand its medical product surveillance capabilities. This workshop will also engage stakeholders to discuss current and emerging Sentinel projects.


Feb 3 : Psychopharmacologic Drugs Advisory Committee Meeting 

Discuss cognitive dysfunction in major depressive disorder (MDD) as a distinct entity:  Consider clinical presentation of cognitive dysfunction in MDD, methods for assessing. Also discuss sNDA for the effectiveness of vortioxetine for the treatment of cognitive dysfunction in MDD, submitted by Takeda Development Center Americas, Inc.


Feb 4 : CDER SBIA Webinar – New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know

New requirement that all DMF Submissions be submitted in electronic Common Technical Document (eCTD) format starting May 5, 2017.  What are the eCTD specifications? Where to find helpful how-to materials on eCTD submissions? Tips for successful submission.


Feb 9 : Arthritis Advisory Committee Meeting 

Discuss BLA for CT-P13, a proposed biosimilar to Janssen Biotech Inc.’s REMICADE (infliximab), submitted by Celltrion, Inc.


Feb 11: Webinar to discuss the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile

Discuss Final Guidance ‘“Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile”


Feb 16-17: Risk Communication Advisory Committee Meeting 

Discuss recent developments in risk communications and related sciences, and possible approaches and applications in the context of FDA communications.


Feb 18: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting 

Discuss and make recommendations on clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology.


Feb 19: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting 

Discuss PMA for DIAM Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA.


Feb 25 : Public workshop “Next Generation Sequencing”-Based Oncology Panels

Obtain feedback on analytical and clinical validation approaches for next generation sequencing (NGS)-based oncology panels.


Feb 24 : Small Business Outreach Vendor Fair


Feb 25-26: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting 

Discuss PMA TOPAS Treatment for Fecal Incontinence by ASTORA Women’s Health, LLC.


Feb 29 : FDASIA 907 Public Meeting: Progress on Enhancing the Collection, Analysis and Availability of Demographic Subgroup Data

Present FDA’s progress in implementing the “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data,” required under Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA). Also seeking feedback and recommendations from stakeholder groups



Mar 2 : Public Workshop – Patient and Medical Professional Perspectives on the Return of Genetic Test Results

To understand patient and provider perspectives on receiving genetic test results


Mar 4 : Vaccines and Related Biological Products Advisory Committee Meeting 

Open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 influenza season.


Mar 14 : Clinical Outcome Assessment Compendium (COA Compendium) 

INFORMATION : To be updated

Mar 15-16 : Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting 

15th – Discuss PMA  for the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System sponsored by Abbott Vascular.

16th – Discuss PMA for the AngelMed Guardian System sponsored by Angel Medical Systems, Inc.


Mar 17: Patient-Focused Drug Development for Psoriasis.

To obtain patient perspectives on the impact of psoriasis on daily life, treatment approaches, treatment selection.


Mar 23 : How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?

Seek comments and proposals from industry, investigators, and regulators on investigational treatment of patients with pre-existing liver diseases (e.g. chronic viral infection with hepatitis C or B, alcoholic and non-alcoholic steatohepatitis, other liver disorders).

Co-sponsored by the FDA-CDER and Critical Path Institute (C-Path)




April 13-14 Public Meeting- Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies

Open discussion on length of pediatric safety studies, successes and challenges, study design and implementation.


Apr 21: Public Workshop – Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids

Discuss  appropriate level of Good Manufacturing Practices (GMPs) regulation to ensure the safety and effectiveness of air-conduction hearing aid devices.




May 4-6Food and Drug Administration/Xavier Medical Device Conference (MedCon)

Topics: Combination Products, FDA Strategic Priorities, Medical Device Innovation Consortium, Supplier Quality and Design, FDA Inspections and Insights, Canada’s Quality System Requirements, EU Medical Device Regulation, FDA submission and Regulatory strategy. Networking opportunity


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