FDA drafts pharma exec prosecution guidelines

The FDA has drafted guidelines for selecting the cases in which it will pursue misdemeanor prosecutions of corporate officers, holding them accountable for lingering GMP breaches and other violations of the Food, Drug and Cosmetics Act. The guidelines are being reviewed internally, reports law firm Bryan Cave, and the regulator expects to make public the final version. Item 

Suggested Articles

A biotech that worked with a nutritional products maker on the API for its clinical-stage radiation drug, is buying all of the manufacturing know-how.

Merck KGaA is selling a manufacturing site and its Allergopharma allergy drug business as it focuses on newer meds.

In a first, the FDA and Indian oversight agencies worked together to block illegal drugs from entering the U.S.