Archive for March 2019

The FDA hit OTC drug manufacturer Tomco-Harwel Industries with an extensive Form 483 for numerous violations at its Tulsa, Oklahoma facility. Source: Drug Industry Daily

The FDA issued a warning letter to Thibiant International for producing defective OTC drugs at its Newbury Park, California manufacturing facility. Source: Drug Industry Daily

UK lawmakers on Friday failed to approve an orderly withdrawal from the European Union, leaving drugmakers and regulators scrambling to make sense of the chaos. Source: Drug Industry Daily

FDA Commissioner Scott Gottlieb and two of his top aides took to the internet Friday to urge drug sponsors to continue treatment for especially needy clinical trial patients after their studies end and before the new treatment is officially approved. Source: Drug Industry Daily

EU regulators flagged 18 percent of inspected biologics and nine percent of inspected drugs for scientific or regulatory problems in the two decades since European regulators began inspecting drugs and medicines, the European Medicines Agency said in a report issued Thursday. Source: Drug Industry Daily

New York’s Attorney General Letitia James on Thursday joined the opioid fray accusing drugmakers and distributors—including Purdue Pharma and its owners, the Sackler family—of unleashing a “plague” that has killed thousands. Source: Drug Industry Daily

It was a lovefest for outgoing FDA Commissioner Scott Gottlieb on Thursday as he testified before the Senate Committee on Appropriations on the FDA’s budget request for fiscal 2020. Source: Drug Industry Daily