In comments on the FDA’s draft guidance on the Usage and Indication sections of drug labeling, Novartis and Pfizer asked the agency to clarify its thinking on limitations of use.…
The FDA proposed a rule Tuesday to allow OTC drugs sterilized by irradiation to be marketed legally without an agency-approved NDA or ANDA. Source: Drug Industry Daily
The FDA hit Guadalajara, Jalisco-based drug manufacturer Jabones y Productos Especializados (Soaps and Specialized Products) with a Form 483 for multiple violations, including serious quality deficiencies, observed during a March…
In the latest salvo in the federal crackdown on fraud among Florida compounders, a federal jury convicted pharmacist Stephen Chalker of participating in a $5 million scheme to defraud Medicare,…
A California federal judge dismissed a shareholder suit against Impax Laboratories alleging price-fixing but left the door open for an amended complaint. Source: Drug Industry Daily
The FDA issued guidance Monday on how sponsors of synthetic drugs should approach post-approval manufacturing process changes — listing examples of low, medium and high risk changes. Source: Drug Industry…
FDA Commissioner Scott Gottlieb announced a revised agreement Friday between the agency and states on interstate distribution of compounded drugs, responding to concerns that the existing distribution limits are too…
More than a year after shutting down its CAR-T trial after subjects died, Juno Therapeutics agreed to pay $24 million to investors who claimed they were not properly informed. Source:…
Three national foundations have committed $30 million to the launch of a not-for-profit generic drug company — first announced in January — citing the rising prices of generics and the…
Maryland’s Attorney General filed charges against Insys Therapeutics over alleged violations of the state’s Consumer Protection Act, saying the company joined local health care providers in an “unfair and deceptive…