The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

  • PDUFA Draft Makes Changes to FDA Mission, Regulatory Pathways

    A new draft of the Prescription Drug User Fee Act ( PDUFA ) legislation that provides nearly half of the US Food and Drug Administration's (FDA) funding makes several significant changes to the agency, reports BioCentury . A discussion draft circulating among House Republicans "includes an updated FDA mission, language intended to expand accelerated approval and incentives for antibiotic drug development." The accelerated approval language is reportedly similar to l...
  • Bill Would Encourage FDA to Seek Expert Advice About Rare Diseases

    Proposed legislation introduced in Congress on 7 March would encourage the US Food and Drug Administration (FDA) to seek and receive advice from experts in the field of rare diseases. The Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 ( EXPERRT Act ) would allow a consultation programs to be established for the purpose of allowing an exchange of expert information. The goal of the program is to allow FDA staff to better inform and strengthen...
  • New Bipartisan Bill to Expand Accelerated Approval Pathway

    [Updated 6 March to Include Link to FAST Act.] An upcoming piece of legislation advanced by Reps. Cliff Stearns (R-FL) and Edolphus Towns (D-NY) would expand the US Food and Drug Administration's (FDA) use of the accelerated approval pathway , reports BioCentury . The Faster Access to Specialized Treatments (FAST) Act is reportedly similar to Sen. Kay Hagan's (R-NC) bill, the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act ,...