Warning Letters Special Report: What Worried The FDA Most About Pharmaceutical Supply Chains
One in five of the drug GMP warning letters the US FDA issued in 2022 raised supply chain concerns. Active pharmaceutical ingredient distribution became a major focal point as agency checked opioid and alcohol-based hand sanitizer supply chains. The year also featured a pair of warning letters to excipient firms, one a Mexican glycerin supplier, and the other a unit of DuPont.
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The Story Behind DuPont’s Unprecedented Excipient Warning Letter And Tips On How To Avoid Another
Insights from the FDA’s Francis Godwin on how the agency came to issue a warning letter to a DuPont excipient plant and how the normally under-the-radar sector can ensure GMP compliance.
CDER Laments Lack Of Shortage Funding, But FDA Didn’t Request New Money For 2024
CDER head is worried FDA won’t be able to sustain gains the agency made on drug shortages and supply chain work as big CARES Act boost set to run out this year, yet it didn’t ask Congress for new taxpayer funding in the fiscal year 2024 budget request.
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.