Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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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.
AMR Alliance Follows Up Global Industry Standard With Responsible Manufacturing Certification
A new voluntary certification from the AMR Industry Alliance and the British Standards Institution will assess pharmaceutical firms’ responsibility and sustainability when it comes to manufacturing antibiotic drugs, in an attempt to control the spread of antimicrobial resistance.