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The FDA on Monday published 28 new product-specific guidances and revised testing recommendations on another 15 therapies to aid ANDA filers in designing bioequivalence studies for their applications. Read More
The FDA has pledged to delay enforcement of key elements of its new track and trace regulations for drugmakers, promising that until May 1 it will take no action against companies that do not capture and transmit product information. Read More
Manufacturers of pandemic flu vaccines will have more leeway in what they submit to the European Medicines Agency, according to final guidance that consolidates the requirements for premarket submissions for all types of influenza vaccines. Read More
The FDA is proposing revisions to an adverse events reporting form that includes, for the first time, a section for large compounders to submit events. Read More
The FDA plans to consolidate its 16 districts overseeing pharmaceutical imports into either four or five districts under a reorganization plan that aims to make inspection policies and procedures more uniform, regardless of port of entry. Read More
The European Medicines Agency released a comprehensive report detailing steps to better prevent and detect fraud and biased medical product reviews by 2016. Read More
Boehringer Ingelheim’s advanced lung cancer drug Vargatef is too expensive to justify the modest benefit it provides patients, according to the UK’s healthcare cost watchdog that recommended against coverage. Read More
The European Medicines Agency has chosen six drugs for initial review under its adaptive pathways pilot project, out of 34 potential candidates. Read More
European regulators approved Novartis’ eye drop drug Travatan to treat pediatric glaucoma patients, expanding patent protection for the treatment by another six months. Read More
The Federal Trade Commission counted 29 pay-for-delay deals in fiscal year 2013 out of a total of 145 patent litigation settlements between brand and generic drugmakers — a slight decline from 2012, but in line with the two previous years. Read More
Generics makers are pressing the FDA to expand its criteria for granting first-generic status to ANDAs, a move that would put more drugs in line for expedited review. Read More