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Three stem cell treatment centers have been hit with an FDA warning letter critical of their recordkeeping and lack of required licenses for their clinical procedures. Read More
The FDA continues to turn up the heat on compounding pharmacies, issuing two warning letters to compounders in Kentucky and California for serious GMP deficiencies related to sterility. Read More
Two lawmakers have unveiled legislation intended to boost the FDA’s ability to hire and retain scientific and technical experts to review drug applications. Read More
The European Medicines Agency has outlined the steps companies should follow once they secure orphan status for a medical product to maintain that status and secure marketing authorization. Read More
An ex-Turing executive took his former employer to task on Thursday, telling lawmakers the drugmaker’s decision to raise the price of Daraprim by 5,000 percent was “unjustified.” Read More
The European Medicines Agency has begun a public consultation on planned revisions to Module V of the good pharmacovigilance practices on risk management systems, which clarifies what risk management plans to focus on over a product’s lifecycle. Read More
Heparin is back in the news, after France’s National Agency for Medicines and Health Products Safety issued a GMP noncompliance statement to China’s Dongying Tiandong Pharmaceutical, which manufactures the active ingredients of Lovenox and heparin. Read More