USP Standards For Biological Drugs Would Restrict Innovation, US FDA Says
Top officials at the US FDA explain why the agency opposes USP monographs for biological products as a Senate committee proposes to disallow them and the USP launches an advertising campaign in their favor.
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USP Rivalry With US FDA Over Compendial Standards Provision Busts Into Open Legislative Fight
In a letter to Senate HELP Committee chairman Sen. Lamar Alexander and ranking member Sen. Patty Murray, USP and other stakeholders are calling for the removal of language that would exclude biological products from requirements to follow USP quality standards.
Transparency Looms Large In US FDA’s Next-Pandemic Legislative Agenda
Agency’s proposals for pandemic preparedness reauthorization would build on CARES Act provisions to gain greater visibility into global pharmaceutical supply chains, while also seeking deeper understanding of manufacturing quality management activities. Also included in FY 2024 budget request: long-sought drug destruction and drug recall authorities.
US FDA ‘Brainstorms’ For Ways To Resume Pre-Pandemic Inspection Cadence
The FDA's drug inspections director discusses trends and challenges in remarks at a Georgia GMP conference, while declining to share specific ideas generated in last week’s agency brainstorming session.