A Florida class-action suit charges Walmart, Aurobindo Pharma, ScieGen Pharmaceuticals and Westminster Pharmaceuticals negligently allowed potentially carcinogenic blood pressure drugs onto the market. Source: Drug GMP Report
Indian drug manufacturer SkyLark CMC drew a warning letter from the FDA by denying the agency investigator access to its manufacturing facility in Ahmedabad, Gujarat. Source: Drug GMP Report
The FDA issued a warning letter to Chinese API maker Zhejiang Huahai, the company implicated in a global recall of contaminated valsartan, for failing to adequately investigate the root cause…
The FDA withdrew a proposed rule in December that would have allowed generic drugmakers to independently update and distribute revised labeling to reflect new safety data. Source: Drug GMP Report
BTS Research is finishing 2018 on a high note BTS Research is pleased to report this year's USDA inspection has been completed with 0 findings. Since BTS incubation in 2001,…
The European Medicines Agency is seeking public comments as it prepares new guidelines for rare allergy clinical trials. Source: Drug Industry Daily
The stalemate over funding for the federal government continues with no further votes scheduled on Capitol Hill this week. Source: Drug Industry Daily
Former Insys CEO Michael Babich has agreed to plead guilty in connection with a kickback scheme involving the company’s Subsys fentanyl spray, the U.S. Attorney for the District of Massachusetts…
The FDA denied a petition from Pharmaceutical Manufacturing Research Services (PMRS) asking the agency to set a higher standard for NDAs for abuse-deterrent opioids for treatment of chronic pain. Source:…
Canada’s Competition Bureau cleared Celgene, Pfizer and Sanofi of allegedly blocking generic competition, ending a two-year investigation. Source: Drug Industry Daily