The World Health Organization releases for comment a working document on quality management system requirements for national regulatory authority insp...
Five stakeholders express appreciation for an FDA draft guidance on considerations for developing therapeutic protein biosimilars and suggest ways the...
The Senate Finance Committee will mark up a bipartisan prescription drug pricing overhaul bill sponsored by Sens. Grassley and Wyden.
FDA warns Indias Indoco Remedies Limited about CGMP and other violations at its Goa drug manufacturing facility.
The DC federal court says FDA should reconsider its exclusivity decision for Indiviors Sublocade that blocked Braeburns Brixadi from approval.
FDA warns High Chemical about CGMP deviations in its production of active pharmaceutical ingredients.
FDA issues a Warning Letter to Curaleaf (Wakefield, MA) for illegally selling unapproved products containing cannabidiol online with unsubstantiated p...
Federal Register notice: FDA makes available a final guidance entitled Postmarketing Safety Reporting for Combination Products Guidance for Industry a...