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November 24, 2015
Pharmaceutical manufacturing facilities can help prevent contamination and cross contamination by using color coding.
November 17, 2015
Operations at Catalent’s Beinheim, France, softgel facility were suspended following suspected deliberate action to misplace capsules.
November 16, 2015
The agency issues guidance on the labeling of over-the-counter products that contain acetaminophen.
November 02, 2015
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.
Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.
October 29, 2015
The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.
USP responds to FDA's draft guidance on the naming of biological products.
October 23, 2015
The agency provides terms and recommendations for packaging and labeling of injectable medical products.
The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards
October 06, 2015
The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.