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In the latest legal twist over generics of Allergan’s blockbuster dry eye treatment, Restasis, Teva is suing the FDA for changing its policy on eligibility for 180-day marketing exclusivity for generics. Read More
The FDA is advocating a shared set of scientific and technical standards for generic drugs to help drive product competition and lower prices, according to Commissioner Scott Gottlieb. Read More
The complaint alleged that the companies failed to “monitor, report and prevent the diversion of prescription opioids” and caused the state “extraordinary municipal costs.” Read More
Leading drugmakers are pushing back against an FDA proposal to require independent safety committees for expansion cohorts in clinical trials. Read More
Committee chairperson Brian Rini said the clinical data supported efficacy in terms of response rate, and that any discrepancies in the safety data were likely simply “what you get when you have a lower number of patients treated in this type of development program.” Read More