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

July

  • 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

  • CDER Small Business Regulatory Education for Industry (REdI) Pharmaceutical Quality Symposium July 20-21, 2016. Meeting Information

August

  • 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

September

October/November

  • 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

Past

  • 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

  • Childhood Cancer Advocacy Forum 2016, Friday, April 22, 2016, FDA White Oak Campus, 10903 New Hampshire Avenue, the Great Room Silver Spring, Maryland 20993. 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
  • The Twentieth FDA CASSS Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products - WCBP 2016. The meeting will be held on January 26, 2016 at The Mayflower Hotel, 1127 Connecticut Ave NW, Washington, D.C. 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
  • FDA Public Workshop: Clinical Trial Designs for Emerging Infectious Diseases, November 9-10, 2015, National Institutes of Health, Natcher Conference Center, Building 45, Bethesda, MD 20894. 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
  • Developing and Using Precision Therapies in the “Omics" Era: Generating and Interpreting Evidence for Rare Subsets: FDA-UVA co-sponsorship workshop, December 12, 2014, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993. Meeting information
  • FDA Outreach to the Pediatric Cancer Advocacy Community, November 18, 2014, FDA White Oak Campus, Bldg. 31 The Great Room A, Silver Spring, MD. Meeting information
  • Development and Regulation of Abuse-Deterrent Opioid Medications; Public Meeting, October 30-31, 2014, Sheraton Silver Spring Hotel, 8777 Georgia Avenue, Silver Spring, MD 20910. Meeting information
  • The FDA, the Critical Path Institute (C-Path) and the Burroughs Wellcome Fund (BWF) are co-sponsoring the “First Annual Neonatal Scientific Workshop – Roadmap for Applying Regulatory Science to Neonates” – October 28 and 29, 2014 – FDA White Oak Campus – Great Room 1503 A. We would like to invite you all to participate in this workshop on October 28 and 29, 2014. Meeting Information
  • Patient-Focused Drug Development Public Meeting and Scientific workshop on Female Sexual Dysfunction, October 27-28, 2014, FDA White Oak Campus. Meeting Information
  • FDA Public Workshop: Innovations in Breast Cancer Drug Development – Next Generation Oncology Trials, Breast Cancer Workshop, October 21, 2014, Hyatt Regency Bethesda Hotel, One Bethesda Metro Center (7400 Wisconsin Avenue), Bethesda, MD 20814. Meeting information 
  • FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Conference Fall 2014; September 18-19, 2014, Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda, MD 20814. Meeting Information
  • FDA/PQRI Conference on Evolving Product Quality, September 16-17, 2014, Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Meeting information
  • Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments, September, 10-11, 2014, The DoubleTree by Hilton Hotel, The Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD. 20910. Meeting information
  • CDER Forum for International Drug Regulatory Authorities, September 8-12, 2014. Meeting information
  • Advancing the Use of Biomarkers and Pharmacogenomics; Notice of Public Meeting; Request for Comments. September 5, 2014. Meeting Information
  • Public Workshop on the Clinical Development of Drugs to Prevent Infections Caused by Staphylococcus Aureus in the Healthcare Setting; September 5, 2014, The DoubleTree by Hilton Hotel, 8727 Colesville Road, Silver Spring, MD 20910. Meeting Information
  • Confidentiality of Interim Results in Cardiovascular (CV) Outcomes Safety Trials; Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER; Request for Comments. August 11, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting Information
  • Regulation of Nonprescription Drug Products – Question and Answer Sessions. August 4-5, 2014. Meeting Information
  • FDA Small Business Regulatory Education for Industry (REdI) Conference Spring 2014, June 16-17, 2014. Meeting Information
  • Public Meeting on Inborn Errors of Metabolism Patient-Focused Drug Development, June 10, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD.  Meeting information
  • Public Workshop: Immune Responses to Enzymes Replacement Therapies: Role of Immune Tolerance Induction. June 9, 2014, FDA White Oak Campus, Bldg. 31, Great Room 1503, Silver Spring, MD. Meeting Information.
  • Third Annual ISPE/FDA Current Good Manufacturing Practices Conference, June 2 – 4, 2014, Hilton Baltimore, 401 W. Pratt Street, Baltimore, MD. Meeting Information
  • Public Workshop: “Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone Health.” Pediatric and Maternal Health Staff in the Center for Drug Evaluation and Research and the Office of Pediatric Therapeutics are announcing a 1-day public workshop, June 3, 2014 White Oak Campus, Building 2, Room 2047, 10903 New Hampshire Avenue, Silver Spring, MD 20993. Meeting Information.  
  • Study Approaches and Methods To Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting; Public Meeting, Request for Comments, May 28-29, 2014, FDA White Oak Campus, Bldg. 31, The Great Room (Rm. 1503), Silver Spring, MD. Meeting information
  • Postmarketing Requirements for the Class-Wide Extended-Release/Long-Acting Opioid Analgesics, May 19-20, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
  • Public Workshop: Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format, May 8-9, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
  • Public Meeting on Pulmonary Arterial Hypertension Patient-Focused Drug Development, May 13, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
  • FY 2014 Regulatory Science Initiatives Part 15 Public Meeting, May 16, 2014, FDA White Oak Campus, Bldg 31, The Great Room, Silver Spring, MD. Meeting information
  • Public Hearing on the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907, April, 1, 2014. FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
  • 2014 GDUFA and You Conference, March 27-28, 2014, Hilton Orlando, Lake Buena Vista, FL. Meeting Information
  • Food and Drug Administration/Xavier University PharmaLink Conference—Leadership in a Global Supply Chain, March 19-20, 2014, Xavier University, 3800 Victory Pkwy.,Cincinnati, OH 45207. Meeting information
  • Public Workshop: Application of Physiologically –Based Pharmacokinetic Modeling to Support Dose Selection, March 10, 2014, FDA White Oak Campus, Bldg. 31, Great Room 1503B and C, Silver Spring, MD.  Meeting Information
  • Over-the-Counter Ophthalmic Drug Products – Emergency Use Eyewash Products; Announcement of Public Hearing; Request for Comments, March 7, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information
  •  IOM/FDA Public Workshop: Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks, February 12-13, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting Information
  • Public Meeting on Sickle Cell Disease Patient-Focused Drug Development, February 7, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information 
  • Nanomaterial Drug Products: Current Experience and Management of Potential Risks, January 14-15, 2014, USP Meeting Center, 12601 Twinbrook Parkway, Rockville, MD 20852. Meeting Information
  • Public Workshop – Complex Issues in Developing Drug and Biological Products for Rare Diseases, January 6-7, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information

 

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