The FDA cited six manufacturers for a variety of issues, including cross-contamination, complaint handling and quality system failures. Source: Drug GMP Report

Three U.S. drug manufacturers were hit with warning letters over shortcomings encountered at their facilities, including data integrity concerns, improper equipment calibration and unproven water systems. Source: Drug GMP Report

The FDA has updated its guidance on changes to risk evaluation and mitigation strategies (REMS) with new details on submissions. Source: Drug GMP Report

CDER released final guidance on submitting next generation nucleotide sequence (NGS) data to support resistance assessments for antiviral drugs. Source: Drug GMP Report

The FDA hit four drugmakers for a variety of issues, including bug infestations, environmental monitoring and poor record keeping. Source: Drug GMP Report

Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on GMP clearance regulations for overseas manufacturing facilities, clarifying the agency’s processing timelines for various applications. Source: Drug GMP Report

Aclaris made misleading claims in a TV ad for its seborrheic keratosis treatment Eskata and failed to include details of potential side effects, CDER’s Office of Prescription Drug Promotion said…

The FDA has asked Merck to team up with IBM, KPMG and Walmart to put together a new pilot program testing whether blockchain can help regulators track and trace prescription…

The FDA is giving a gentle but clear nudge to industry on stem cells with a new rapid-response program to help regenerative medicine makers to get on the right side…

The FDA hit two U.S. and one Taiwanese drugmaker for a variety of shortcomings at their facilities, including quality oversight, inadequate testing and faulty equipment. Source: Drug GMP Report