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Inadequate personnel training, non-implementation of quality control procedures and scuttle fly larva found on employee clothing are among the litany of observations from an FDA Form 483 levied on Shanghai-based CARsgen Therapeutics. Read More
The FDA has released two draft guidances on how sponsors can prepare for bioresearch monitoring inspections (BIMO) in both their marketing applications as well as prior to and during the BIMO inspections themselves. Read More
Novartis has taken up the legal sword against Maryland and West Virginia over state legislation that would widen the powers of the controversial 340B program. Read More
More than 70,000 Zantac cases may go to trial following Delaware Superior Court Judge Vivian Medinilla’s order allowing plaintiffs’ expert witnesses to testify in court that the drug may cause cancer. Read More
In responding to an FTC/HHS request for information (RFI) on how drug wholesalers and group purchasing organizations (GPOs) influence generic drug shortages, the trade group for generic and biosimilar drug manufacturers has requested an investigation of the drug buyers’ practices. Read More
How can regulators judge the efficacy and safety of a product that makes patients feel so good, so quickly, that trial blinding is impossible, and the drug’s positive effects may carry abuse potential? Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
This edition of Quick Notes focuses on FDA drug approvals for relapsed or refractory lymphoma, a nighttime non stimulant liquid ADHD treatment for children, extensive-stage non-small cell lung cancer and an mRNA vaccine for RSV. Read More
Bkemv, like Soliris, has a boxed warning that states that eculizumab products increase the risk of serious and life-threatening meningococcal infections. Read More
Novo Nordisk has sued nine more companies for selling products billed as containing semaglutide, a primary ingredient in the Danish pharma’s popular weight loss drug Wegovy. Read More