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

March 2017

  • Applying Regulatory Science to Neonates: Third Annual Scientific Workshop, March 27-29, 2017, Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, Maryland 20852. Meeting informationdisclaimer icon

April 2017

  • 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
  • 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
  • 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

May 2017

  • 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
  • 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  

June 2017

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Past

  • 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
  • 9th Annual Sentinel Initiative Public Workshop. The meeting will be held February 2, 2017 at Barbara Jordan Conference Center, 1330 G St NW, Washington, DC 20005. Meeting Informationdisclaimer icon
  • 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
  • 9/12-14/16: PDA/FDA Annual Joint Regulatory Conference - 25th Anniversary: Aligning Manufacturing Goals with Patient Needs through Successful Innovation and Compliance disclaimer icon
  • 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
  • Drug Interactions with Hormonal Contraceptives; Public Health and Drug Development Implications; Public Meeting, November 9, 2015, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Section A of the Great Room (Rm. 1503), Silver Spring, MD 20993. Meeting information
  • Scientific Workshop on Labeling “Lower” Dose Estrogen-Alone Products for Symptoms of Vulvar and Vaginal Atrophy (VVA), November 10, 2015, FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Room 1503 B and C, Silver Spring, MD 20993. Meeting information
  • Public Webinar: Health Canada and United States Food and Drug Administration - Joint Public Consultation on International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, November 12, 2015, Webinar. Meeting information
  • FDA Scientific Workshop: Osteoporosis Drug Development - Moving Forward, November 4, 2015, FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Room 1503 B and C, Silver Spring, MD 20993. Meeting information
  • FDA Small Business Regulatory Education for Industry (REdI) Conference "Prescription Drug Labeling - Challenges and Issues", November 3-4, 2015 Meeting information
  • Public Meeting on Patient-Focused Drug Development for Nontuberculous Mycobacterial Lung Infections, October 15, 2015, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Room 1503 B and C (the Great Room), Silver Spring, MD 20993. Meeting information
  • Sixth Annual Coalition Against Major Diseases (CAMD)/FDA Scientific Workshop; Public Workshop, October 15, 2015, FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center, (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, MD 20993. Meeting Information
  • Risk Evaluation and Mitigation Strategies (REMS): Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access, October 5-6, 2015, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Room 1503), Silver Spring, MD 20993-0002. Meeting information
  • FDA Regulatory Education for Industry (REdI) Conference Fall 2015 Meeting Information
  • Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop, September 28, 2015, Residence Inn Marriott, 2850 South Potomac Avenue, Arlington, VA 22202. Meeting information
  • Public Meeting on Patient-Focused Drug Development for Huntington’s and Parkinson’s Diseases, September 22, 2015, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center (the Great Room), Silver Spring, MD 20993-0002. Meeting information
  • FDA/DIA Oligonucleotide Based Therapeutics Conference 2015 (FDA/DIA 2015 Conference), September 9 -11 2015. Grand Hyatt Washington 1000 H. Street, NW; Washington, DC 20001. Meeting Information
  • FDA Public Workshop: Ovarian Cancer Endpoints Workshop, September 3, 2015, 10903 New Hampshire Avenue Building 31, Room 1503 B & C (Great Room), Silver Spring, MD 20993. Meeting information
  • Quality Metrics Public Meeting, August 24, 2015, 8:30-5:00 p.m., FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Room 1503 B and C (the Great Room), Silver Spring, MD 20993. Meeting information
  • FDA Small Business Regulatory Education for Industry (REdI) Conference “Focus on CGMPs and FDA Inspections” July 15-16, 2015. Meeting Information
  • Exploring Naloxone Uptake and Use – A Public Meeting, July 1-2, 2015, FDA White Oak Campus, Bldg. 31 The Great Room 1503A Silver Spring, MD. Meeting information
  • FDA-AACR: Dose Finding Workshop, May 18-19, 2015, Washington Court Hotel, 525 New Jersey Avenue, NW, Washington, DC 20001. Meeting information
  • Preparation for International Conference on Harmonization Steering Committee and Expert Working Group Meetings in Fukuoka, Japan; Public Meeting, May 15, 2015, FDA White Oak Campus 10903 New Hampshire Avenue Bldg. 31, Room 1503A Silver Spring, MD 20993. Meeting information
  • Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework After a Quarter-Century, April 20-21, 2015.Meeting information
  • Public Workshop on Assessment of Neurocognitive Outcomes in Inborn Errors of Metabolism and Advancing the Development of Pediatric Therapeutics: Assessment of Neurocognitive Outcomes, April 16 -17, 2015.  Meeting Information
  • Public Meeting on Breast Cancer Patient-Focused Drug Development, April 2, 2015, FDA White Oak Campus, Bldg. 31 The Great Room 1503A Silver Spring, MD. Meeting information
  • PDUFA V Clinical Outcome Assessments, Public Workshop, April 1, 2015, FDA White Oak Campus, Bldg. 31, Room 1503A (Great Room), Silver Spring, MD. Meeting information
  • Public Meeting on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, March 27, 2015, FDA White Oak Campus, Bldg. 31, Room 1503 (Great Room), Silver Spring, MD. Meeting Information
  • FDA/Xavier University PharmaLink Conference-Leadership in a Global Supply Chain, March 25-27, 2015, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207. Meeting Information
  • Measuring Dystrophin in Dystrophinopathy Patients and Interpreting the Data, March 20, 2015, FDA White Oak Campus, , 10903 New Hampshire Ave., Bldg. 31, Room 1503A (Great Room), Silver Spring, MD. Meeting information
  • FDA-AAPS-ACCP-ASCPT Co-sponsored Workshop - Evaluating and Modernizing our Approaches for Food-Effect Assessment February 2-4, 2015, Renaissance Baltimore Harbor Place Hotel, 202 East Pratt Street, Baltimore, MD 21202. Meeting Information
 
2014 Meetings are archived. To view them, please see the FDA Archive.

 

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