Drugs

Meetings, Conferences, & Workshops (Drugs)

The following are meetings, conferences, and workshops sponsored or co-sponsored by the Center for Drug Evaluation and Research (CDER):

Upcoming

September 2017

  • Primary Pediatric Hypertension Workshop: Epidemiology and Treatment Gaps, Monday, September 25, 2017, 6710B Rockledge Drive, 1st Floor Conference Rooms (1425/1427) Bethesda, MD 20817. Meeting information
  • Eighth Annual Predictive Safety Testing Consortium (PSTC) / FDA CDER Scientific Workshop, September 21, 2017, FDA White Oak Campus, Silver Spring, MD. Meeting information
  • Reducing the Risk of Preventable Adverse Drug Events associated with Hypoglycemia in the Older Population, September 12, 2017, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993. Meeting information
  • Pediatric Trial Design and Modeling: Moving into the next decade. September 8, 2017. Food and Drug Administration, 10903 New Hampshire Ave. Building 31, Great Room, Silver Spring, MD 20993. Meeting Information
  • Public Workshop: A Framework for Regulatory Use of Real-World Evidence, Sept 13, 2017, 9:00 am to 4:00 pm, 1777 F Street Conference Center, 1777 F Street NW, Washington, DC 20006. Meeting information disclaimer icon 
  • FDA-ASCO: Hematology and Oncology Fellows Day Workshop, September 15, 2017, FDA White Oak Campus, Building 22, Conference Room 2205, Silver Spring MD, 20993. Meeting information
  • Regional Anesthesia Public Workshop, Monday, September 18, 2017, Marriot Residence Inn Bethesda Downtown, 7335 Wisconsin Avenue, Bethesda, MD 20814. Meeting Information  
  • Regional Anesthesia Public Workshop: a forum to discuss the current state of knowledge regarding peripheral nerve blockade, September 18, 2017, Marriott Residence Inn Bethesda Downtown, 7335 Wisconsin Avenue, Bethesda, MD 20814   More Information
  • FDA Small Business Regulatory Education for Industry (REdI): Fall Conference September 27-28, 2017, Hilton Rockville Hotel, Rockville, MD. Meeting Information

October 2017

  • Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review; Public Workshop, October 2 - 3, 2017,  Silver Spring, MD 20993. Meeting information 
  • CDER SBIA extended webinar: Electronic Drug Registration & Listing Using CDER Direct - October 5, 2017 Meeting Information
  • Demonstrating Equivalence of Generic Complex Drug Substances and Formulations,  October 6, 2017 from 8:00 a.m. to 4:00 p.m. at FDA’s White Oak campus 10903 New Hampshire Ave, Building 31 (The Great Room 1503B+C), Silver Spring, MD 20903-0002. Meeting information
  • Health Canada and FDA Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, October 19, 2017 from 9:00 a.m. to 12:00 p.m.  at Sir Frederick G. Banting Research Centre, 251 Sir Frederick Banting Driveway, Ottawa, ON K1Y 0M1, Canada. Meeting Information 
  • Overcoming Barriers to Product Development, Regulatory Approval and Commercialization of Affordable, High Quality, Generic Topical Dermatological Drug Products; Public Workshop October 20, 2017 (8:30am – 4:30pm) FDA White Oak Campus, 10903 New Hampshire Avenue Bldg. 31, Room 1503 (Great Room) Silver Spring, Maryland 20993. Meeting information
  • 2017 DIA/FDA Oligonucleotide-based Therapeutics Conference.  October 25-27, 2017.  Bethesda North Marriott Hotel and Conference Center, North Bethesda, MD 20852.  Meeting Information
  • Drug Development in Pediatric Heart Failure:  Extrapolation, Clinical Trial Design, and Endpoints Public Workshop Announcement,  October 27, 2017 from 8:00 am to 5:00 pm at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503A, Silver Spring, MD 20993-0002. Meeting Information
  • CDER Rare Diseases Public Workshop: Strategies, Tools and Best Practices for Effective Advocacy in Rare Diseases Drug Development, October 30, 2017, FDA White Oak Campus, 10903 New Hampshire Avenue Bldg. 31, Room 1503 (Great Room) Silver Spring, Maryland 20993. Meeting information 

November 2017

  • FDA-ASCO Public Workshop: Geriatric Oncology Workshop, November 6, 2017 from 8:00 am to 5:00 pm,  FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Room 1503 - Great Room B & C, Silver Spring, MD 20993. Meeting information

  • FDA-NCI Public Workshop: Defining Disease Recurrence and Harmonizing Conduct in Adjuvant Bladder and Kidney Cancer Trials, November 28, 2017, National Institutes of Health, Natcher Conference Center (Building 45), Room E1/E2, 9000 Rockville Pike, Bethesda, MD 20892. Meeting information

December 2017

  • FDA Public Workshop: Assessment of Cardiovascular Toxicities in Immuno-oncology Trials, Monday, December 1, 2017, 8:00 a.m. – 5:00 p.m., FDA’s White Oak campus 10903 New Hampshire Ave, Building 31 (The Great Room 1503), Silver Spring, MD 20903-0002. Meeting Information
  • Public Workshop on Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input, Monday, December 18, 2017, 9:00 a.m. – 5:00 p.m., FDA’s White Oak campus 10903 New Hampshire Ave, Building 31, Room 1503 (The Great Room A), Silver Spring, MD 20903-0002. Meeting Information

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Past

2017

  • Public Meetings: Enhanced Drug Distribution Security under the Drug Supply Chain Security Act, August 23, 2017, 9 am to 4 pm, FDA White Oak campus, 10903 New Hampshire Ave, Building 31, Great Room (Room 1503), Silver Spring, MD 20903.  Meeting information
  • Sixth Annual FDA-ISPE Quality Conference, June 5-7, 2017, Arlington, VA.. Meeting information 
  • Safe Use Symposium: A Focus on Reducing Preventable Harm from Drugs in the Outpatient Setting, June 15, 2017, The public symposium will be held at FDA’s White Oak campus, 10903 New Hampshire Ave, Building 31 (The Great Room C), Silver Spring, MD 20903. Meeting information
  • 2017 PDA/FDA Biosimilars Conference, June 26-27, 2017, Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, MD 20814. Meeting information
  • Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of  Present and Future Capabilities, July 10, 2017, 8:30 am to 5 pm and July 11 2017, 8:30 am to 5 pm, Sheraton Hotel, 8777 Georgia Avenue, Silver Spring, MD 20910. Meeting information
  • Developing Rabies Monoclonal Antibody Products as a Component of Rabies Post-exposure Prophylaxis; Public Workshop, July 17, 2017, 8:30 am to 5:00 pm, FDA White Oak campus, 10903 New Hampshire Ave, Building 31, Great Room (Room 1503), Silver Spring, MD 20903. Meeting information
  • Administering the Hatch-Waxman Amendments:  Ensuring a Balance Between Innovation and Access; Public Meeting, July 18, 2017, 9 am to 5 pm, FDA White Oak campus, 10903 New Hampshire Ave, Building 31, Great Room (Room 1503), Silver Spring, MD 20903. Meeting information
  • Development of New Tuberculosis Drug Regimens-Scientific and Clinical Design Considerations, July 19, 2017, 8:30 a.m. to 5:00 p.m. Eastern Time, FDA White Oak campus, 10903 New Hampshire Ave., Building 31, Great Room, Silver Spring, MD 20993. Meeting information
  • FDA-AACR: Oncology Dose Finding Workshop Part 3, July 20, 2017, W Washington DC, 515 15th Street NW, Washington, DC 20004. Meeting information
  • Sentinel Training at the Food and Drug Administration; Public Workshop,  July 10, 2017, 10 am to 4 pm, White Oak campus, FDA White Oak campus, 10903 New Hampshire Ave, Building 31, Great Room (Room 1503), Silver Spring, MD 20903. Meeting information
  • FDA-PDS Symposum, May 2, 2017, Marriott Bethesda North, Bethesda, Maryland Meeting Information 
  • FY 2017 Generic Drug Research Public Workshop, May 3, 2017, to obtain input from industry and other interested stakeholders on the identification of regulatory science priorities for FY 2018. FDA White Oak Campus, Silver Spring, MD. Meeting information
  • FDA Small Business Regulatory Education for Industry (REdI): Spring Conference May 9-10, 2017, Renaissance Atlanta Midtown Hotel, Atlanta, GA Meeting Information
  • Training for Opioid Analgesic Prescribers, May 9-10, 2017, Location, Sheraton Silver Spring, 8777 Georgia Avenue, Silver Spring, MD. Meeting information
  • Public workshop: Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research, May 12, 2017, from 9 a.m. to 3 p.m. EDT, at FDA’s White Oak campus 10903 New Hampshire Ave, Building 31 (The Great Room A, B, and C), Silver Spring, MD 20903. Meeting information  
  • 11th Annual DIA/FDA Statistics Forum, This meeting, including tutorials, will be held on April 24-26, 2017, 8:30 am - 4:30 pm, at Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Meeting information
  • International Council for Harmonization Regional Public Consultation, April 24, 2017, FDA White Oak Campus, 10903 New Hampshire Avenue, Building 51 Room 1503A, Silver Spring, MD 20993.  Meeting information
  • FDA/C-Path PRO Consortium: Second Annual Workshop on Clinical Outcome Assessments (COAs) in Cancer Clinical Trials, April 25, 2017, 1 Bethesda Metro Center, Bethesda, MD 20814. Meeting Information
  • Antibody Mediated Rejection in Kidney Transplantation Public Workshop.  The meeting will be held  April 12, 2017, 8:00 am to 6:00 pm Eastern Time and April 13, 2017 8:30 am to 1:30 pm Eastern Time, at the Tommy Douglas Conference Center, 10000 New Hampshire Ave, Silver Spring, MD, 20903. Meeting information
  • CDER Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI): Generic Drugs Forum April 4-5, 2017. Doubletree by Hilton, Silver Spring, MD. Meeting information
  • FDA/PhUSE Computational Science Symposium.  March 19-21, 2017, Silver Spring Civic Center, 1 Veterans Place, Silver Spring, Maryland 20910.  Meeting Information
  • Current State and Further Development of Animal Models of  Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa Public Workshop.  The meeting will be held  March 1, 2017, 8:30 AM to 5:00 PM, at the DoubleTree by Hilton Hotel Washington DC-Silver Spring, 8727 Colesville Rd, Silver Spring, MD 20910 , Meeting information
  • FDA and USP Workshop on Standards for Pharmaceutical Products-“Critical Importance of Excipients in Product Development – Why Excipients are Important Now and In the Future”, February 27-28, 2017, Rockville, MD. Meeting Information
  • FDA-ASCO Hematology and Oncology Fellows Day Workshop,  February 23, Rockville, MD. Meeting Information

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2016

  • FDA-PDS Symposium. This meeting will be held on November 29, 2016 in Bethesda, MD Meeting Information
  • Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products (as announced in the notice of availability for the draft guidance General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products), October 31 and November 1, 2016, College Park Marriott Hotel and Conference Center, 3501 University Blvd. East Hyattsville, MD 20783. Meeting information
  • FDA/CDER and ASTM Workshop on Standard for Pharmaceutical Products, October 11, 2016, FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD  20993. Meeting Information
  • Immuno-oncology Drug Development Workshop, October 13-14, 2016, Hyatt Regency Washington on Capitol Hill in Washington, DC.  Meeting information
  • Public Meeting: Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act, October 14, 2016, FDA White Oak Campus, 10903 New Hampshire Avenue Building 31, Room 1503A (Great Room), Silver Spring, MD 20993. Meeting information
  • Biosimilar User Fee Act Public Meeting, October 20, 2016, 10903 New Hampshire Avenue, Bldg. 31 Room 1503, (Great Room sections B/C), Silver Spring, MD 20993. Meeting information
  • Scientific Workshop on Erythropoietic Protoporphyria (EPP), Monday, October 24, 2016, FDA White Oak Campus, 10903 New Hampshire Avenue Building 31, Room 1503A (Great Room), Silver Spring, MD 20993. Meeting information
  • Health Canada and FDA Joint Public Consultation on International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, October 24, 2016, Sir Frederick G. Banting Research Centre, 251 Sir Frederick Banting Driveway, Ottawa, ON K1Y 0M1, Canada. Meeting information
  • Co-Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices, September 29, 2016, Sheraton Silver Spring Hotel, 8777 Georgia Ave, Silver Spring, MD 20910. Meeting information
  • FDA Small Business Regulatory Education for Industry (REdI) Conference September 27-28, 2016.  Meeting Information
  • FDA Public Workshop: Cardiovascular Toxicity Assessment in Oncology Trials, September 22, 2016, FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Room 1503 A (Great Room), Silver Spring, MD 20993. Meeting information
  • FDA-ASCO: Hematology and Oncology Fellows Day Workshop September 16, 2016, FDA's White Oak campus, 10903 New Hampshire Ave. Silver Spring, MD 20993.  Meeting Information
  • The Global Bioequivalence Harmonization Initiative: EUFEPS-AAPS Second International Workshop, September 15-16, 2016, Rockville Hotel & Executive Meeting Center, Rockville MD.  Meeting Information
  • Anti-Infective Drug Development in Neonates, September 15, 2016, Sheraton Silver Spring Hotel, 8777 Georgia Ave, Silver Spring, MD 20910. Meeting information
  • PDUFA Public Meeting August 15, 2016
  • ICH Q3D Regional Workshop, August 22-23, 2016, Location: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Room 1503 B/C, Silver Spring, MD 20993. Meeting information
  • Public Workshop: Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c), August 29, 2016 from 9:00am to 5:00pm, FDA’s White Oak campus, 10903 New Hampshire Ave., Building 31 (The Great Room A, B, and C), Silver Spring, MD 20993. Meeting information
  • CDER Small Business Regulatory Education for Industry (REdI) Pharmaceutical Quality Symposium July 20-21, 2016. Meeting Information
  • Facilitating Antibacterial Drug Development for Patients with Unmet Need and Developing Antibacterial Drugs that Target a Single Species. The meeting will be held July 18-19, 2016. Meeting Information
  • 3rd Annual Drug Discovery and Development Symposium for Pulmonary Hypertension. The meeting will be held July 11-12, 2016 in Bethesda, MD. Meeting Information
  • Clinical Trial Design Considerations and Laboratory Testing Technologies for Malaria Drug Development, June 30, 2016, FDA's White Oak campus, 10903 New Hampshire Ave., Building 31 Great Room, Silver Spring, MD 20993. Meeting information
  • FDA-AACR (American Association for Cancer Research): Oncology Dose Finding Workshop, June 13, 2016, Walter E. Washington Convention Center, Washington, DC. Meeting Information
  • Public Meeting: Over-the-Counter Monograph User Fees, June 10, 2016, FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, Room 1503, Silver Spring, Maryland 20993 Meeting Information
  • Fifth Annual FDA-ISPE Quality Conference. The meeting will be held June 5-8, 2016 in Bethesda, MD. Meeting information
  • FY 2016 Regulatory Science Initiatives Part 15 Public Meeting, May 20, 2016, White Oak Campus, Silver Spring, Maryland. Meeting Information 
  • Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation Workshop, May 19, 2016, White Oak Campus, Silver Spring, Maryland.  Meeting Information

  • Mechanisms to Improve Awareness and Transparency of Expanded Access Processes and Programs; Public Workshop. This meeting will be held on May 16, 2016, in Silver Spring, MD, 8:30 a.m. to 11:45 a.m. Meeting Information
  • FDA Small Business Regulatory Education for Industry (REdI) Conference May 2016, Bloomington, MN. Meeting Information

  • Accelerating Anticancer Agent Development and Validation Workshop (AAADV), May 4-6, 2016, Bethesda North Marriott Hotel and Conference Center, Bethesda, Maryland. Meeting information

  • International Council for Harmonization Regional Public Consultation, May 6, 2016, 10903 New Hampshire Ave., Building 51, Rm 1503A, Silver Spring, Maryland. Meeting information

  • The 10th Annual FDA/DIA Statistics Forum 2016, April 25-27, 2016, Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, Bethesda, Maryland 20852. Meeting information

  • Evaluation of the Safety of Drugs and Biological Products used during Lactation, April 27 - 28, 2016, White Oak Campus, Silver Spring, Maryland.  Meeting Information

  • Workshop on Clinical Outcome Assessments (COAs) in Cancer Clinical Trials. This meeting will be held April 26, 2016, in the Sheraton Silver Spring Hotel, Silver Spring, MD. Meeting information

  • AAPS/ITC Joint Workshop on Drug Transporters in ADME. This meeting will be held April 18-20, 2016, in Baltimore, MD.  Meeting Information

  • The FDA CDER & ASCPT Annual William B. Abrams Memorial Lectureship. The meeting will be held April 20, 2016, in White Oak, Maryland. Meeting Information

  • Seventh Annual Predictive Safety Testing Consortium (PSTC) / FDA CDER Scientific Workshop. The meeting will be held April 25, 2016, on the FDA White Oak Campus, in Silver Spring, Maryland.  Meeting Information

  • Public Workshop- Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies, April 13-14, 2016, Double Tree by Hilton Hotel - Bethesda, 8120 Wisconsin Avenue, Bethesda, Maryland 20814. Meeting Information
  • FDA Small Business Regulatory Education for Industry (REdI): Generic Drugs Forum 2016, April 13-14, 2016, Double Tree by Hilton Hotel, 8727 Colesville Road, Silver Spring, MD Meeting Information
  • Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshop.  The meeting will be held on Thursday April 14 from 9AM- 5PM and Friday, April 15 from 8AM-4PM at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, Bethesda, Maryland.  Meeting Information
  • 2016 DILI Conference XVI:  How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?  The meeting will be held Wednesday and Thursday, March 23-24, 2016 at the Marriott Inn & Conference Center, University of Maryland University College 3501 University Blvd., East Hyattsville, MD  20783.  Meeting Information
  • How to Navigate CDER Workshop for Advocacy Groups. The workshop will be held on Thursday, March 31, 2016, from 8:30 a.m. to 5 p.m. FDA White Oak Campus, 10903 New Hampshire Avenue, The Great Room (Room A, B and C), Silver Spring, MD, 20993.  Meeting Information 
  • Second Annual Neonatal Scientific Workshop, March 7-8, 2016, FDA White Oak Campus, Silver Spring, Maryland.  Meeting Information
  • Primary Sclerosing Cholangitis (PSC) Workshop with the FDA, AASLD, ACG, AGA and NASPGHAN. The meeting will be held March 3- 4, 2016 on the FDA White Oak Campus, in Silver Spring, Maryland. Meeting Information 
  • Arthritis Foundation & Food and Drug Administration Accelerating OA Clinical Trials Workshop. The meeting will be held February 23- 25, 2016 in the Atlanta Airport Hilton, Atlanta, GA. Meeting Information
  • 8th Annual Sentinel Initiative Public Workshop, Wednesday, February 3, 2016 from 9:00 AM to 4:00 PM (EST), Renaissance Washington, DC Dupont Circle Hotel | 1143 New Hampshire Avenue Northwest | Washington, DC 20037. Meeting Information

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2015, 2014 Meetings are archived. To view them, please see the FDA Archive.

 

 

Page Last Updated: 09/14/2017
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