Australia’s Therapeutic Goods Administration reached the end of its three-year transition period to the 2016 version of ISO 13485 and devicemakers using the updated standard to show Quality Management System…
The FDA issued a proposed rule aimed at modernizing mammography quality standards and better positioning the agency to act when violations are found. Source: The GMP Letter
Two breast implant manufacturers were served with warning letters after the FDA found they failed to comply with post-approval study requirements. Source: The GMP Letter
The FDA is considering a total product lifecycle monitoring approach to emerging artificial intelligence devices, the agency said in a proposed rulemaking issued April 2. Source: The GMP Letter
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released guidance for EU drugmakers shipping medicines by air freight to the UK in the event of a no Brexit agreement.…
The FDA hammered five drug manufacturers — one Indian and four American — for varying issues at their drug making facilities, sending the companies Form 483s for their violations. Source:…
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