Blogs

The US Food and Drug Administration (FDA) has reached a deal with pharmaceutical industry representatives that will give the agency an additional two months to review new drugs and raise user fees by 6%. The agreement comes after months of closed-door negotiations aimed at smoothing the way for reauthorization of the Prescription Drug User Fee Act (PDUFA), which is set to expire in October 2012. FDA has published a draft letter summarizing its performance goals and procedures related to the law’s reauthorization. Similar talks between the agency and medical device industry continue.

Read more:

• US FDA, pharma agree new user fee deal (Pharma Times)
• FDA and drugmakers agree to extend user fee plan (Associated Press)
• FDA may get two more months to review new drugs (Reuters)
• FDA, industry seek extended reviews for new drugs (FierceBiotech)
• PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 Through 2017 (FDA.gov)