Cook Pharmica recently received commercial approval from the FDA for a drug product and did so with the FDA waiving the otherwise required pre-approval inspection (PAI). Cook Pharmica is a pharma and biopharma CDMO. According to a company statement, the approval of this drug product will help fill a void for patients in need, which resulted from a known, national drug shortage of a product currently listed on the FDA’s Drug Shortage Index. Tedd Green, president of Cook Pharmica, commented, “We...