enforcement

2 Observations on GSK Vaccines Unit ’483

FDA has released the Form FDA-483 issued following a 2/19-2/27 inspection at the GSK Vaccines licensed biological drug manufacturing unit in Marburg, Hassia, Germany. The two inspection observations were:

failure to validate the cleaning procedures for dedicated equipment used in the manufacture of aluminum hydroxide adjuvant to prevent contamination or carry-over when the adjuvant is a component in several of the company’s licensed U. S. products; and
failure to thoroughly review any unexplained discrepancy, whether or not the batch has already been distributed.

FDA Warns Amgen Over Misleading Vectibix Promotional Video

FDA has issued a Warning Letter to Amgen over a promotional video for its colorectal cancer drug Vectibix (panitumumab) because it omitted all safety information and failed to disclose important limitations on the drug’s approved uses. In the just-posted 8/12 Warning Letter, CDER’s Office of Prescription

Court Rejects Novo Nordisk Bid to Block Lilly’s GLP-1 Advertising

A federal judge has denied Novo Nordisk’s request for a preliminary injunction blocking Eli Lilly from running allegedly misleading advertisements comparing its GLP-1 drugs Zepbound and Mounjaro with Novo’s Wegovy and Ozempic, finding that Novo failed to demonstrate irreparable harm. In a 10/26 opinion, U.S.

FDA Releases 79 More Form 483 Inspection Records

FDA published another 79 Form 483 inspection records on 10/26 through the Office of Inspections and Investigations FOIA Electronic Reading Room, continuing a series of substantial disclosures of previously unavailable inspection documents. Their availability is part of the agency’s expanded transparency initiative (see earlier story), but a significant

AdvaMed Urges FDA to Use Existing Regulatory Framework for GenAI

AdvaMed is asking FDA to build on its existing regulatory framework for generative AI (GenAI)-enabled medical devices instead of creating new frameworks that could hinder innovation. In comments responding to an FDA discussion paper, AdvaMed said utilizing GenAI in medical devices “should not fundamentally alter the core principles that

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FDA Warns Amgen Over Misleading Vectibix Promotional Video

Court Rejects Novo Nordisk Bid to Block Lilly’s GLP-1 Advertising

FDA Releases 79 More Form 483 Inspection Records

AdvaMed Urges FDA to Use Existing Regulatory Framework for GenAI