The FDA issued 483s to five drugmakers for inadequate good manufacturing practices observed by agency investigators during inspections of their facilities. Source: Drug GMP Report

Four drugmakers drew warning letters from the FDA for quality failures including testing and other deficiencies. Source: Drug GMP Report

The FDA has issued a revised draft guidance on complying with labeling requirements for the pregnancy and lactation subsections of prescription drug and biological product labeling. Source: Drug GMP Report

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) continues to extend what it calls temporary “flexibilities” in good manufacturing practice (GMP) to drugmakers to help out with the exceptional…

FDA Commissioner Stephen Hahn said that the agency will resume domestic inspections this month using a new risk assessment system developed in response to the pandemic. Source: Drug GMP Report

Public Citizen has petitioned the FDA to require a black box warning for sodium-glucose cotransporter-2 (SGLT2) inhibitors used off-label for treatment of type 1 diabetes. Source: Drug GMP Report

The FDA has released guidance for drugmakers on good manufacturing practices (GMPs) for responding to COVID-19 infection in employees. Source: Drug GMP Report

After a lengthy review, the U.S. Pharmacopeia (USP) has decided to continue recommending the use of decades-old reagents derived from horseshoe crab blood for detecting endotoxins in drugs rather than…

Nabriva Therapeutics drew a second complete response letter (CRL) from the FDA for its injected antibiotic Contepo (fosfomycin), but said the problem was not related to the drug’s safety or…

The FDA hit a La Habra, California compounding pharmacy with a warning letter for repeated violations, including dirty equipment and the presence of insects. Source: Drug GMP Report