Five American drugmakers were hit with warning letters after the FDA discovered an assortment of issues at their facilities, including contamination risks, missing procedures and issues with cleaning. Source: Drug…

The FDA released a final guidance on pediatric labeling of prescription drugs that, among other recommendations, calls for black box warnings on medicines with inactive ingredients that might be dangerous…

Some Australian drugmakers are still figuring out how to pass muster during the Therapeutic Goods Administration (TGA)’s new pharmacovigilance inspections introduced in 2017, according to the TGA’s first metrics report.…

CDER plans to release 93 new or revised guidances for drugmakers in 2019, including more than a dozen on drug quality and chemistry, manufacturing and controls. Source: Drug GMP Report

The FDA issued its first warning letter under the Drug Supply Chain Security Act (DSCSA), hitting McKesson for violating verification requirements and allegedly shipping illegitimate product. Source: Drug GMP Report

FDA Commissioner Scott Gottlieb announced agency action against 17 companies for selling unapproved Alzheimer’s treatments. Source: Drug GMP Report

Drugmaker and pharmacist groups called on the FDA to amend its draft guidance on supply chain verification systems, saying the draft doesn’t account for the varying conditions at facilities. Source:…

FDA Commissioner Scott Gottlieb highlighted the agency’s plans to expand data collection on adverse event reporting in his Feb. 27 testimony before a key House appropriations subcommittee. Source: Drug GMP…

The FDA issued Form 483 reports to a trio of drugmakers for various quality issues observed during inspections. Source: Drug GMP Report

The FDA issued a series of warning letters to three foreign and two U.S. drugmakers, faulting them for violations ranging from inadequate aseptic processing areas to use of APIs subject…