Xavier Initiative Aims to Develop Good Supply Practices
When Xavier University convened a group of pharmaceutical manufacturing supply chain quality experts to find out why they have such problems with their suppliers, they discovered a surprising root cause: their own companies. Now they’re identifying steps the industry can take to improve the situation.
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The user fee legislation Congress approved June 26 makes quality risk management a GMP requirement, further pressuring pharmaceutical manufacturers to make sure they are protecting their global supply chains. The bill directs FDA to inspect based on risk rather than time or location, and to rely on trusted foreign inspectorates, while adding new user fees for generic drugs that will boost funding for further expansion of the agency’s inspectorate.
US FDA hits firms in New Jersey, South Korea and China with warning letters. Meanwhile, Catalent and several outsourcing facilities work on Form 483 inspection findings as Mylan, Viona and Lohxa announce drug recalls.
US Supply Chain In Brief: White House Aims To Deliver With Block Stowing And Industrial Base Expansion
Biden administration works to expedite medical supplies and expand medical countermeasures production, while US FDA's DSCSA anti-counterfeiting paperwork burden estimate surges.