Despite EU requirements for clinical trials to report results to the EU Clinical Trials Register within a year of a trial’s completion, sponsors have only reported about half of them…

In comments on the first of four FDA patient experience data guidances, Allergan and Roche urged the agency to add more details on data that can be used in labeling.…

The FDA issued 54 product-specific draft guidances Thursday that offer recommendations for developing 15 generic versions of drugs it says need competition. Source: Drug Industry Daily

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…

Drugs targeting the central nervous system take significantly longer to develop and get approved than other meds, according to a new analysis. Source: Drug Industry Daily

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.…

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.…

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. Source: Drug…

The FDA hit Montreal-based drugmaker Lernapharm (Loris) with a warning letter over serious sterility violations and air filtration problems that were not resolved after a December 2017 inspection. Source: Drug…

A federal appeals court Monday upheld a lower court ruling that invalidated four Acorda Therapeutics patents for the multiple sclerosis drug Ampyra (dalfampridine). Source: Drug Industry Daily