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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more details on how it would show regulatory flexibility to developers of drugs for rare diseases, saying recent draft guidance is unclear about what may or may not be appropriate.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
The FDA approved GlaxoSmithKline’s injectable drug Nucala Wednesday for use in patients 12 years and older suffering from severe asthma attacks. It is intended to be used in conjunction with other asthma drugs. Read More
Allegations of price gouging within the pharmaceutical industry reached fever pitch in Washington, D.C., yesterday, with House members calling for hearings, a Senate committee opening an investigation into pricing practices and HHS announcing a hearing on the subject. Read More
Mylan may move forward with its proposed hostile takeover bid of Perrigo, as long as it divests seven generic drugs, the FTC has determined. The move is the final regulatory hurdle for Mylan’s bid and eases the FTC’s concerns that the deal would harm competition. Read More