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The European Medicines Agency wants to bring its policy on accessing drug safety reports in line with pharmacovigilance legislation, which aims to simplify reporting and increase data sharing among international organizations. Read More
The FDA will grant marketing exclusivity only to biologics that are fundamentally different from existing products, according to a new guidance that explains what manufacturers must do to lock in protection from biosmiliar competition. Read More
Two industry groups in India are suing the country’s drug regulatory authority for enacting price controls on scores of branded-generic drugs to treat diabetes and cardiovascular disorders. Read More
The European Medicines Agency is seeking suggestions on promising techniques to identify genomic biomarkers that might spur development of targeted therapies. Read More
Sponsors of companion diagnostics should submit applications to the FDA simultaneously with the drug product submission to improve the chances that the test on which the treatment relies is available when the drug is approved, an FDA final guidance says. Read More
The U.S. biotechnology industry has endorsed a recent World Health Organization proposal to give biosimilar products a unique name qualifier that distinguishes them from the reference products’ nonproprietary name, a proposal that may run counter to naming protocols in the generic drug industry. Read More
The FDA expects to collect $312.2 million in generic drug user fees next fiscal year, with companies paying slightly less for each ANDA filing and facilities that produce active pharmaceutical ingredients (API) and finished generic products paying more. Read More
Two years after the EU implemented landmark pharmacovigilance legislation, European regulators are offering manufacturers and other interested parties a comprehensive look at how the region’s drug safety system actually operates. Read More
The U.S. House passed a bill this week that aims to prevent prescription drug abuse and diversion, while ensuring patient access to needed medications, by fostering greater collaboration between drug manufacturers, distributors and regulators. Read More