ARTICLE | Politics & Policy
PhRMA critical of FDA labeling proposal for accelerated approval
May 31, 2014 12:30 AM UTC
The Pharmaceutical Research and Manufacturers of America said FDA's proposal to include a section on limitations of use and uncertainty about clinical benefit on the labels of drugs with accelerated approval could create confusion among healthcare providers and the public as to whether the products have met the safety and efficacy requirements for FDA-approved drugs. PhRMA's concern came in comments on March draft guidance released by FDA on the topic. ...