Archive for July 2019

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 in an untitled letter to the firm. Source: Drug GMP Report

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 drugs along the increasingly complex supply chain. Source: Drug GMP Report

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 of the law. Source: Drug GMP Report

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

The FDA’s ad police warned a Campbell, Calif.-based company to stop claiming that its prescription diet pill can help patients lose weight three times faster than diet and exercise alone. Source: Drug GMP Report

As part of its ongoing enforcement efforts against drug compounders, the FDA plans to move the program’s base of operations from CDER’s Office of the Center Director to the Office of Compliance, Director Janet Woodcock announced. Source: Drug GMP Report

The House Appropriations committee approved nearly $3.3 billion in spending for the FDA for fiscal year 2020 and once again nudged the agency to get going on its delayed continuous manufacturing initiative. Source: Drug GMP Report