FDA holding public meeting for PDUFA reauthorization

FDA will hold a public meeting on Oct. 24 to discuss PDUFA reauthorization. This month, the agency published formal details of the reauthorization deal it negotiated with the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA). The deal would impose 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 Extra, Sept. 1). ...