Washington state regulators have awarded AbbVie an exclusive contract to help the state rid itself of Hepatitis C within the next decade—the nation’s second state to adopt a subscription payment…
Drugmakers and regulators urgently need to create a pipeline of drugs to treat the growing threat of antibiotic-resistant diseases, the World Health Organization says in a new report issued Monday.…
The FDA hit Patheon Pharmaceuticals with a Form 483 for equipment and quality violations at its Cincinnati, Ohio facility. Source: Drug Industry Daily
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…
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…
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…
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:…