Drugs

Repeat CGMP Violations at Northland Nuclear Medicine

A 5/26-5/29 FDA inspection at the Northland Nuclear Medicine drug manufacturing facility in Bismarck, ND, found repeat current good manufacturing practice (CGMP) violations in the firm’s production of positron emission tomography (PET) drugs. A 10/22 Warning Letter says the firm’s PET drugs are adulterated due to these CGMP violations:

failure to conduct adequate investigations and take appropriate corrective action when a failure of a production batch or any component of the batch failed to meet any of its specifications; and
failure to adequately follow procedures to ensure that all equipment is clean, suitable for its intended purpose, properly installed, maintained, and capable of repeatedly producing valid results.

he letter notes that FDA discussed similar violations with the company at a 12/13/2023 regulatory meeting and that Northland had proposed specific remediation for the violations. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says.

The agency recommends that Northland engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

The company was told to address the violations promptly and to ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence.

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