The FDA recently updated its Investigations Operations Manual chapter on inspections of domestic and international sites. Source: Drug Industry Daily

The FDA approved a second gene therapy for cancer, adding Kite Pharma’s lymphoma treatment Yescarta (axicabtagene ciloleucel) to the fledgling list. Source: Drug Industry Daily

The University of Michigan Medical Center processed and compounded drugs under unsanitary conditions, the FDA said in a warning letter. Source: Drug Industry Daily

An Atlanta federal judge found several individuals and their two firms in contempt for violating court orders over the sale of deceptively marketed weight-loss supplements, imposing a judgement of more…

Sen. Claire McCaskill (D-Mo.) introduced a bill that would repeal 2016 legislation that she believes weakened the Drug Enforcement Administration’s ability to go after opioid distributors. Source: Drug Industry Daily

An FDA advisory committee voted Wednesday to recommend that the FDA approve semaglutide, Novo Nordisk’s drug candidate for Type 2 diabetes. Source: Drug Industry Daily

The FDA cited a Vital Laboratories facility in Gujarat, India over failure to investigate out of specification results, conditions for material storage, and employee training. Source: Drug Industry Daily

A Colorado dietary supplement manufacturer wrongfully included potentially harmful ephedrine alkaloids in one of its products and made improper claims for drug-like effects from others, the FDA said in a…

The FDA’s draft guidance on post-approval manufacturing changes for biological products needs work to clarify how it fits with previous agency documents, according to written comments on the draft, which…

Health Canada has proposed fee hikes for reviewing applications for approval of new drugs, for oversight of drug manufacturing facilities, for postmarket monitoring of drug sales and for other regulatory…