• Woodcock Testifies on PDUFA, FDA Drug Approval Performance

    The US Food and Drug Administration's (FDA) top drug regulator, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, testified Friday, 30 March before the Senate Health, Education, Labor and Pensions (HELP) Committee to advocate for the expedited approval of the Prescription Drug User Fee Act (PDUFA) and to tout FDA's historical accomplishments and its path forward. Speaking on the PDUFA legislation, Woodcock said the legislation has "led to ...
  • Woodcock Calls for Prescription Drug Tracking System

    The US Food and Drug Administration (FDA) is calling for a prescription drug tracking system to ensure the pharmaceutical supply chain's integrity, reports The Financial Times . Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, testified before the House Energy and Commerce Committee on 8 March and called for Congress to grant FDA additional authority to secure the supply chain. "Currently there is no complete record of all parties who have b...
  • Woodcock Touts FDA Success in Drug Approval

    The US Food and Drug Administration's (FDA) Director for the Center for Drug Research and Evaluation (CDER), Janet Woodcock, testified before the House Energy and Commerce Committee on 8 March to advocate for the passage of the Prescription Drug User Fee Act ( PDUFA ) and used the opportunity to tout FDA's recent drug approval accomplishments. Woodcock, the nation's top drug regulatory official, was also happy to cite numbers showing FDA was able to approve most drugs ...
  • 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 ...