The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    NIH kicks off COVID-19 vaccine, monoclonal antibody research network

    The National Institutes of Health (NIH) today announced the kickoff of a national clinical trials network to test vaccines and other treatments that could prevent infection with SARS-CoV2, the virus that causes infection with the novel coronavirus COVID-19.   The network has been established by the National Institute of Allergy and Infectious Diseases (NIAID) through the merger of four previously existing clinical trials networks that focused on HIV/AIDS.   “Star...
  • Regulatory NewsRegulatory News

    Public Funds Help Late-Stage Development of About 25% of New Drugs, Study Finds

    One in four new drugs approved in the US between January 2008 and December 2017 received direct funding from public resources for late stage research or through spin-off companies created from public research institutions, a study published in the BMJ on Wednesday found.  As the drug pricing debate has accelerated in recent months, the debate over whether public or private entities do the majority of drug development work has continued, with the general assumption tha...
  • Regulatory NewsRegulatory News

    FDA’s Woodcock Weighs in on Role of NIH in Drug Development

    US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday that while the National Institutes of Health (NIH) has been instrumental to drug discovery and development, she does not think NIH or academics should be in the business of developing new pharmaceuticals. The comments came as part of the first day of a two-day meeting at the National Academies of Sciences, Engineering and Medicine in Washington, DC...
  • Regulatory NewsRegulatory News

    Foreign Threats to NIH Research: Senate Finance Committee Digs In

    China, Russia and Iran were singled out in a Senate Finance Committee hearing on Wednesday as countries that are looking to either undermine or usurp scientific research conducted with US taxpayer funds. Committee Chairman Chuck Grassley (R-IA) made clear that China is “by far the most prolific offender,” offering the example of attempts by Chinese researchers to steal genetically modified corn seeds in Iowa and send them back to China. “Researchers who are secretly ...
  • Regulatory NewsRegulatory News

    How Biopharma Companies Use NIH and Vice Versa

    An argument has been brewing on Capitol Hill and elsewhere that boils down to the theory that US taxpayers are fronting billions of dollars’ worth of public research that translates into early-stage products that are later sold to companies, go on to win FDA approval and then reap millions or billions in sales, although the government never sees a dime of those earnings. With the help of a new Congressional Research Service (CRS) report published Friday and some other m...
  • Regulatory NewsRegulatory News

    Trial Transparency: NIH Says Final Rule From 2017 has Helped

    Almost a year ago, the National Institutes of Health (NIH) made effective a new policy to better disseminate information from NIH-funded clinical trials through ClinicalTrials.gov, and the agency says that so far, it’s seen some improvements. Back in 2007, section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) established a requirement that "applicable clinical trials" must be registered and information must be submitted to Clinicaltrials.gov. ...
  • Regulatory NewsRegulatory News

    HHS Secretary Working With Trump on a Plan to Reduce Drug Prices

    Health and Human Services Secretary Tom Price told a House appropriations subcommittee on Wednesday that his agency is working with President Donald Trump on a plan to bring down the cost of pharmaceutical drugs. Citing Trump’s numerous mentions since he took office of a plan for a new "bidding" system, Price said skyrocketing drug prices is an issue that members of Congress on both sides of the aisle are looking to target. In defending Trump’s proposed "skinny" budge...
  • Regulatory NewsRegulatory News

    21st Century Cures Act Deadlines Approach in March and June

    The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March. Among those provisions of the law that must be acted upon within 90 days of the law’s enactment (or by 13 March) inc...
  • Leahy Looks to Amend ‘Cures’ Bill as Senate Prepares for Passage

    Sen. Patrick Leahy (D-VT) on Tuesday proposed an amendment to the 21st Century Cures bill that would make it more difficult for brand name drugmakers to halt or delay generic or biosimilar competition. The amendment, supported by the Generic Pharmaceutical Association on Tuesday, would promote competition by further encouraging manufacturers to share product samples with generic and biosimilar companies so that more of these lower-cost treatments can be approved by th...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA

    Lingering for more than two years, the revamped 21st Century Cures bill, unveiled in late November, has now been approved by the House and Senate and President Barack Obama has said he will sign it. The 996-page bill includes major tweaks to the way in which the US Food and Drug Administration (FDA) regulates drugs, devices and biologics, while providing the agency with $500 million over 10 years to implement provisions that seek to move such products to patients more qu...
  • Regulatory NewsRegulatory News

    A ‘Cures’ Revival? Congress Looks to Lame Duck Session to Pass Bill Overhauling FDA, NIH

    With the election just eight days away, House and Senate Republicans are working hard to re-shape a wide-ranging bill lingering for more than two years that would overhaul the way the US Food and Drug Administration (FDA) reviews medical devices and significantly increase (to the tune of almost $9 billion over five years) funding for the National Institutes of Health (NIH), among other major changes. Last month, Senate Majority Leader Mitch McConnell (R-KY) and House Spe...
  • Regulatory NewsRegulatory News

    Final Rule on Clinical Trial Transparency: Will it be Enough to Encourage More Compliance?

    The National Institutes of Health (NIH) on Friday issued a final rule that its leaders said is expected to result in “rapid increases” in the percentage of trials registered and shared via  ClinicalTrials.gov , though it remains to be seen if the $10,000 per day penalties that can be assessed by the US Food and Drug Administration (FDA) will be strictly enforced. Writing in a JAMA Viewpoint on Friday, NIH Director Francis Collins and other senior leaders said: “Inves...