Tuesday, December 10, 2019

Tuesday, December 10, 2019

FDA plans 24 public meetings in November


The U.S. Food and Drug Administration (FDA) has scheduled 24 public meetings, conferences and workshops for November, the agency reported.

Such meetings can be on the following topics: advisory committee agendas; animal and veterinary; biologics; combination products; cosmetics; drugs; food; medical countermeasures; science and research, and tobacco products.

---

FDA Meetings, Conferences and Workshops for November

Start DateEnd DateEventEvent TypeCenter
Nov. 4Nov. 4FDA Genetic Toxicology Workshop: How Many Doses of a DNA Reactive (Ames-positive) Drug can be Safely Administered to Healthy Subjects?WorkshopCenter for Drug Evaluation and Research
Nov. 4Nov. 4Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard TherapiesPublic HearingCenter for Biologics Evaluation and Research
Nov. 4Nov. 4Webinar - Clinical Decision Support Software: Draft GuidanceWebcastCenter for Devices and Radiological Health
Nov. 4Nov. 4Health Canada and United States Food and Drug Administration Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human UseAnnualCenter for Drug Evaluation and Research
Nov. 5Nov. 5CDRH Industry Basics Workshop: 513(g) Requests for Information and Custom Device Exemption - November 5, 2019WorkshopCenter for Devices and Radiological Health
Nov. 6Nov. 6FDA-MRA Approaches to Neoadjuvant Treatment in Melanoma: A Public WorkshopWorkshopCenter for Drug Evaluation and Research
Nov. 6Nov. 7November 6-7, 2019: General Hospital and Personal Use Devices Panel of the

Medical Devices Advisory Committee Meeting Announcement

Advisory Committee MeetingCenter for Devices and Radiological Health
Nov. 6Nov. 6Webinar - Safer Technologies Program: Draft GuidanceWebcastCenter for Devices and Radiological Health
Nov. 6Nov. 6The Role of Ontology and Controlled Terminology in Precision Medicine: Implications

for Post-Market Surveillance

WebcastOffice of the Commissioner, Office of Regulatory Science and Innovation
Nov. 7Nov. 7Promoting Effective Drug Development Programs: Opportunities and Priorities for

FDA’s Office of New Drugs

WorkshopCenter for Drug Evaluation and Research
Nov. 7Nov. 7Webinar - Safety and Performance Based Pathway Performance CriteriaWebcastCenter for Devices and Radiological Health
Nov. 8Nov. 8Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting AnnouncementAdvisory Committee MeetingCenter for Biologics Evaluation and Research
Nov. 12Nov. 12Advancing the Development of Pediatric Therapeutics (ADEPT 6): Pediatric Clinical

Trial Endpoints for Rare Diseases With a Focus on Pediatric Patient Perspectives

WorkshopOffice of the Commissioner
Nov. 13Nov. 14November 13-14, 2019: Immunology Devices Panel of the Medical Devices Advisory Committee Meeting AnnouncementAdvisory Committee MeetingCenter for Devices and Radiological Health
Nov. 13Nov. 13November 13, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting AnnouncementAdvisory Committee MeetingCenter for Drug Evaluation and Research
Nov. 14Nov. 14November 14, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting AnnouncementAdvisory Committee MeetingCenter for Drug Evaluation and Research
Nov. 14Nov. 14Technical and Logistical Considerations for Examining FDA-Regulated Products at International Mail Facilities using Handheld and Field-Portable Analytical DevicesWebcastOffice of the Commissioner
Nov. 14Nov. 14Webinar - Changes to Existing Medical Software Policies Resulting from Section 3060

of the 21st Century Cures Act: Final Guidance

WebcastCenter for Devices and Radiological Health
Nov. 18Nov. 18Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-MakingMeetingCenter for Drug Evaluation and Research
Nov. 18Nov. 19Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the

United States

WorkshopCenter for Drug Evaluation and Research
Nov. 21Nov. 21Office of Minority Health and Health Equity Public Meeting on Strategies to Improve Health Equity Amidst the Opioid CrisisMeetingOffice of the Commissioner
Nov. 21Nov. 21Pediatric Stakeholder Meeting - A Public MeetingMeetingOffice of the Commissioner
Nov. 21Nov. 21CTTI Monthly Webinar: Patient Engagement in Action: Insights from Patients &

the FDA

WebcastCenter for Drug Evaluation and Research
Nov. 22Nov. 22Blood Products Advisory Committee November 22, 2019 Meeting AnnouncementAdvisory Committee MeetingCenter for Biologics Evaluation and Research
Source: U.S. Food and Drug Administration

Organizations in this Story

U.S. Food and Drug Administration (FDA)

More News

FDA Health News