The Knowledge Shelf

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

CGMP/Finished Pharmaceuticals/Adulterated

The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an ANDA referencing that NDA drug product.

CGMP/Finished Pharmaceuticals/Adulterated

CGMP/Finished Pharmaceuticals/Adulterated

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications

Lonza Guangzhou Pharmaceutical Ltd. | 10/31/25 | 483