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The European Medicines Agency has approved a controversial policy that grants researchers access to detailed clinical trial data submitted in support of drug approvals. Read More
Drugmakers planning to market generic and biosimilar products in Brazil should pair up with the branded firms to facilitate the application process, according to an updated rule aimed at speeding generic approvals. Read More
Companies exporting drugs from India were supposed to include barcodes featuring identification codes and serial numbers on all primary-level packaging by July 1, but the union government has postponed that date indefinitely. Read More
India’s National Pharmaceutical Pricing Authority has set price controls on scores of branded generic drugs to treat diabetes and cardiovascular disorders, a decision one industry observer warns will discourage introduction of patented drugs as R&D drug companies worry that price controls may come to their sector as well. Read More
The EU’s drugs authority is advising manufacturers that routine inspections will now include a focus on compliance with pharmacovigilance reporting requirements. Read More
In a blow to AbbVie’s efforts to head off generic competition on its AndroGel 1%, the FDA said Irish drugmaker Perrigo’s testosterone gel product is bioequivalent and interchangeable. Read More
European regulators say there is not enough evidence to conclude that emergency contraceptives lose their effectiveness in women weighing 165 pounds or more, as one manufacturer had cautioned in its product labeling. Read More