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.

  • Regulatory NewsRegulatory News

    FDA Seeks Tweaks to Right-to-Try Bill in House E&C Hearing

    The House Energy & Commerce Committee on Tuesday held a hearing to discuss a "Right-to-Try" bill passed in the Senate that the US Food and Drug Administration (FDA) is seeking to change. The hearing discussed a bill that would seek to undercut FDA’s oversight of a program, known as expanded access, whereby terminally ill patients and their doctors can request access to an investigational drug outside of a clinical trial. Right-to-Try laws have now passed in 37 states...
  • RAPS' LatestRAPS' Latest

    Video: FDA Commissioner Scott Gottlieb's Keynote Speech at the 2017 Regulatory Convergence

    • 28 September 2017
    US Food and Drug Administration Commissioner Scott Gottlieb addressed attendees of RAPS’ 2017 Regulatory Convergence on 11 September. He focused his remarks on making the clinical end of drug development more efficient and effective . If you missed it or would like to see his presentation again, the video is embedded below.
  • Regulatory NewsRegulatory News

    FDA Transparency: Gottlieb Outlines What’s Coming

    FDA Commissioner Scott Gottlieb has been at the forefront of the Washington, D.C. conference circuit this week discussing new work that the agency he leads will undertake, with discussions Thursday at a Politico event, a speech Wednesday at the Friends of Cancer Research, a speech Monday at RAPS' Convergence and a speech last week at the National Health Research Forum. On Thursday, Gottlieb highlighted a few upcoming moves that the agency plans to make in terms of t...
  • Regulatory NewsRegulatory News

    Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies

    FDA commissioner Scott Gottlieb on Monday explained to attendees of RAPS’ Regulatory Convergence conference some steps FDA is taking to make the clinical end of drug development more efficient and effective. Opening with a discussion of the ways in which the gap of time between the discovery of the science behind new treatments and the adoption of such treatments has been shrinking, Gottlieb outlined a few of the ways in which the agency is modernizing its approach t...
  • RAPS' LatestRAPS' Latest

    UPDATE: FDA Commissioner Scott Gottlieb to Deliver Keynote at RAPS Regulatory Convergence

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, will address the global regulatory community on 11 September, delivering keynote remarks at the 2017 Regulatory Convergence conference at National Harbor on the DC Waterfront. The commissioner's keynote presentation was originally scheduled to take place during the opening plenary session, but is now scheduled as a lunchtime session on Monday, 11 September. The Convergence will take place 9–12 Septem...
  • Regulatory NewsRegulatory News

    Nature Editorial: FDA Needs Help Assessing Cutting-Edge Tech

    • 07 August 2017
    The US Food and Drug Administration (FDA) is increasingly being tasked with evaluating cutting-edge therapies and technology that its in-house expertise may not be able to address, according to a Nature editorial, which recommends academic scientists help the agency. Using the example of the 12 July meeting of the Oncologic Drugs Advisory Committee that voted unanimously in favor of the benefit-risk profile for the first of a new kind of cancer therapy, the ed...
  • Regulatory NewsRegulatory News

    Gottlieb: FDA Will Delay Sending Layoff Notices

    In an email to agency staff on Monday, FDA Commissioner Scott Gottlieb said he will delay issuing layoff notices until after 30 September 2017, when the agency's current user fee agreements expire, if Congress has not passed legislation to reauthorize the agreements by then. Previously, FDA has said it would need to begin issuing layoff notices to thousands of employees that are funded by user fees if the agreements are not enacted by 1 August, as agencies are typically ...
  • Regulatory NewsRegulatory News

    FDA Commissioner Vows to Eliminate Backlog of Orphan Drug Designation Requests

    At a Senate hearing on President Donald Trump's FY2018 budget request for the US Food and Drug Administration (FDA), Commissioner Scott Gottlieb vowed to eliminate the backlog of orphan drug designation requests and said he will soon release "modern and risk-based" tools for assessing new treatments, especially for rare diseases and conditions with no effective treatments. "Right now we have a backlog of about 200 orphan drug designation requests where we haven't respond...
  • Regulatory NewsRegulatory News

    Gottlieb: FDA Hiring Freeze Lifted, Plans for Increased Generic Competition Coming

    US Food and Drug Administration (FDA) commissioner Scott Gottlieb was in the hot seat on Thursday to defend President Donald Trump's budget plan to the House appropriations subcommittee, though the conversation quickly dovetailed away from the billion-dollar user fee increase proposed, and revealed that FDA as of Thursday is no longer subject to a federal hiring freeze. While Gottlieb noted that he "wasn't involved in the formulation of the budget," as he's only bee...
  • Regulatory NewsRegulatory News

    Gottlieb Establishes FDA Committee to Confront Opioid Crisis

    Newly-confirmed US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday began to address what he deems to be his "highest initial priority," which is to "reduce the scope of the epidemic of opioid addiction." As a first step, Gottlieb announced the establishment of an Opioid Policy Steering Committee to bring together some of the agency’s senior career leaders to explore and develop tools or strategies to confront the crisis. The initial quest...
  • Regulatory NewsRegulatory News

    Gottlieb to FDA Staff: Immediate Challenge is Opioid Abuse

    Scott Gottlieb, the US Food and Drug Administration’s (FDA) new commissioner, addressed agency staff for the first time late Monday, telling them that "unquestionably, our greatest immediate challenge is the problem of opioid abuse." "This is a public health crisis of staggering human and economic proportion. The epidemic of opioid addiction is not a problem that FDA can solve alone. But we have an important role to play in reducing the rate of new abuse, and in g...
  • Regulatory NewsRegulatory News

    10 Hot-Button Issues FDA’s New Commissioner Will Face

    Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency. Opioid Epidemic At the forefront of the agenda is what Gottlieb called his "highest immediate priority" in the confirmation hearing: the opioid crisis. While acknowledging that FDA’s past actions may have been too incremental, Gottlieb will now have to deal with ...