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The FDA issued 54 product-specific draft guidances Thursday that offer recommendations for developing 15 generic versions of drugs it says need competition. Read More
The FDA issued guidance Wednesday recommending technical specifications and general considerations on how certain comparative clinical endpoint bioequivalence study data and skin adhesion and irritation/sensitization study data for ANDAs should be submitted using FDA-supported data standards. Read More
The FDA issued a warning letter to Longood Medicine, a Beijing-based drugmaker, for process control violations and for using an unapproved drug in the formulation of one of its products. Read More
Seven states have asked a federal appeals court to reconsider its July 20 denial of tribal immunity in a patent case involving Allergan’s controversial Restasis patent transfer to the St. Regis Mohawk tribe. Read More
Seven hospital organizations sued HHS Tuesday to try to force it to impose a final rule on 340B drug pricing transparency that’s been pending for nearly two years. Read More