FDA unveils PDUFA V details

FDA on Thursday published details of the PDUFA reauthorization deal it negotiated with the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA). As BioCentury reported in June, the deal imposes a new 60-day filing review period, effectively adding two months to PDUFA deadlines for NDAs for new molecular entities and original BLAs (see BioCentury, June 6).

FDA has agreed to measures in PDUFA V that are intended to enhance communication with drug sponsors throughout the development cycle, including adding staff to act as liaisons between companies and reviewers and scheduling more meetings with sponsors during reviews. The deal includes funding for FDA regulatory science initiatives, including establishing standards for conducting and assessing meta-analyses, advancing the use of biomarkers and pharmacogenomics, and facilitating the use of patient-reported outcomes as trial endpoints. ...