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Manufacturers of new biologics could receive up to eight years of exclusivity in 12 countries under the Trans Pacific Partnership, a close reading of the deal shows. The specific terms of the contentious trade pact, which President Barack Obama inked with 11 other countries in October, were publicly released Nov. 6. Read More
The European Medicines Agency outlines the basic steps companies should follow when conducting post-approval efficacy studies to ensure the data meet regulatory standards for EU member-countries. Read More
To spur greater mutual inspection reliance between the FDA and EU, the agency and Congress are working to grant the EMA access to unredacted inspection reports. Read More
On Thursday, the FDA approved Gilead’s Genvoya, a once-daily complete regimen for adults and pediatric patients 12 years of age and older with HIV-1 infection. Read More
While there is no set timeframe for the release of FDA’s final quality metrics guidance, the agency has plans to recruit volunteers to conduct a “dry run” in the spring to test the collection and sending of data to the agency. Read More
Drugmakers want the FDA to provide more details on how it would show regulatory flexibility to developers of drugs for rare diseases, saying recent draft guidance is unclear about what may or may not be appropriate. Read More