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The FDA and Customs and Border Protection (CBP) yesterday began accepting applications for an 18-month pilot of a “trusted trader” program to reduce inspections and oversight of imports from drugmakers that establish tough internal import control programs of their own. Read More
Drugmakers operating in the EU must submit additional information to the European Medicines Agency on their authorized products starting immediately, and update previously submitted information by year’s end. Read More
Drugmakers hoping to market generic and biosimilar products quickly in Brazil should pair up with the branded firms to facilitate the application process, according to an updated rule that aims to speed generic approvals. Read More
Drugmakers submitting regulatory filings in the U.S., Europe and Japan generally may use pharmacopeia texts on dosage units interchangeably in the three regions, according to a final FDA guidance that adopts guidelines from the International Conference on Harmonization. Read More
The FDA plans to clear up questions about the types of off-label information drugmakers may communicate to physicians and payers in a series of guidances planned for later this year that will address four key areas that have long tripped up industry. Read More
Teva cleared a major hurdle last week in its bid to launch a generic version of Bristol-Myers Squibb’s hepatitis B drug Baraclude after a federal appellate court upheld a lower court’s decision invalidating the drug’s patent. Read More
Manufacturer Hospira’s 2005 withdrawal of its leucovorin injection was not done for effectiveness or safety reasons, the FDA said, paving the way for new ANDAs on the generic anemia drug. Read More
Makers of drugs to treat opioid-induced constipation need not conduct further large, long-term cardiovascular outcomes safety trials, an FDA advisory panel concluded last week, instead urging the agency to require postmarket observational studies. Read More
The European Medicines Agency (EMA) approved a controversial policy last week that will grant researchers access to detailed clinical trial data submitted in support of drug approvals. Read More