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April 2019

No. 321


Full Issue of Drug GMP Report in PDF Format

Download and view the full issue. Read More

CDER Lists Planned Guidances for 2019

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. Read More

TGA Lists Pharmacovigilance Deficiencies in First Inspection Metrics Report

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. Read More

FDA Lays Out Final Rules for Pediatric Labeling

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 to babies and children. Read More

Warning Letter Roundup: Five Firms Warned for Serious Violations

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. Read More

483 Roundup: FDA Cites Five Drugmakers for GMPs, Other Issues

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. Read More

MHRA Issues Guidance for Air Shipping Medicines in No-Deal Brexit

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. Read More