• PDUFA Witness List Revealed, Hearing Set for Wednesday

    The US House Energy and Commerce Committee's Subcommittee on Health is set to hold a hearing on Wednesday, 1 February on the reauthorization of the Prescription Drug User Fee Act IV (PDUFA) , which is set to expire later this year. The hearing, entitled " Reauthorization of PDUFA : What It Means for Jobs, Innovation, and Patients ", will feature: Commissioner of the US Food and Drug Administration (FDA) Margaret A. Hamburg, MD President of Pfizer's Specialty Care a...
  • Dates for PDUFA, MDUFA, GDUFA Committee Hearings Announced, Top FDA Officials to Testify

    The Energy and Commerce Committee of the US House of Representatives announced Thursday that its Health Subcommittee will hold hearings on the Prescription Drug User Fee Act (PDUFA) reauthorization,  Medical Device Use Fee (MDUFA) Act reauthorization, and the authorization of the Generic Drug User Fee Act (GDUFA). The subcommittee will hold its first hearing on PDUFA on 1 February and call US Food and Drug Administration (FDA) Commissioner Margaret Hamburg ...