Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
Antibacterial Drugs: FDA Panel To Explore Approval Path For Single-Species Agents
US agency’s advisory committee will weigh the pros and cons of five possible development and regulatory pathways, with a specific focus on animal models.
RoxyBond Gets US Advisory Panel OK For Abuse-Deterrent Claim Despite Excipient Concerns
Members unanimously endorse product and mostly supported abuse-deterrent language; several panelists suggest warning about possible harmful effects of excipients by abusing product intravenously.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.