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  • Regulatory NewsRegulatory News

    FDA to Congress: Pediatric Information Lacking in 36% of Relevant Orphan Drug Labels

    In a report to Congress, the US Food and Drug Administration said that there is a public health need for additional pediatric information in labeling for over one-third of approved orphan indications that are relevant in the pediatric population. FDA research, conducted as part of the FDA Reauthorization Act of 2017  (FDARA), found that of all drugs that were approved for an orphan indication between 1 April 1999 and 31 August 2018, a total of 548 orphan indications we...
  • Regulatory NewsRegulatory News

    House Committee Proposes 6% Increase in FDA Funding for FY 2020

    The House Appropriations Committee on Wednesday released a draft fiscal year 2020 funding bill for the US Food and Drug Administration (FDA), calling for a $184 million increase in discretionary funding over 2019’s enacted level.   Total funding for FDA, including revenue from user fees, is $5.86 billion, according to the bill. That total is slightly less than the $6.1 billion requested by the Trump Administration for FDA.   “Within this total, the Committee prov...
  • Regulatory NewsRegulatory News

    Bipartisan Group of Lawmakers Urge Permanent Repeal of Device Tax

    A bipartisan team of eight Congressional leaders are circulating a “Dear Colleague” letter to urge fellow members of Congress to permanently repeal of the 2.3% medical device excise tax before it is reinstated next year. The device tax has only been in effect for two years—between 2013 and 2015—since it was introduced in 2010 under the Affordable Care Act . From device firms and industry groups to patient advocacy groups and health research organizations, the push agai...
  • Regulatory NewsRegulatory News

    Lawmaker Seeks Answers to OIG’s Findings on FDA’s Cybersecurity Policies

    A recent report from the Office of the Inspector General (OIG) “highlighted some very important issues” where the US Food and Drug Administration (FDA) “has room for improvement,” Sen. Chuck Grassley (R-IA) argued in a letter to FDA Commissioner Scott Gottlieb.   The 9 November letter from Grassley, chairman of the Senate Judiciary Committee, follows on the heels of the findings and recommendations OIG at the US Department of Health and Human Services outlined in a...
  • Regulatory NewsRegulatory News

    Democrats, Republicans Prep to Take Up Drug Prices Together

    Following the House’s transition Tuesday to a Democratic majority, Senate Majority Leader Mitch McConnell (R-KY) said Wednesday that he will work with House Democrats on crafting a plan to tackle high prescription drug prices.   “I can’t imagine that won’t be on the agenda,” McConnell said regarding prescription drug prices. Potential House speaker Nancy Pelosi (D-CA) also further indicated that representatives and senators on both sides of the aisle will look to find ...
  • Regulatory NewsRegulatory News

    Opioids Compromise: What’s in it for FDA

    The US House and Senate late Tuesday reached a consensus on a conglomeration of opioids legislation that will have far-reaching effects for the US Food and Drug Administration (FDA). Among the provisions that will affect FDA include allowing the agency to require prescription opioids to be packaged in a three- or seven-day blister packs, further collaboration with the Customs and Border Protection (CBP) to stop illegal opioids at the border, new public meetings and guid...
  • 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

    Congressional Spending Deal Offers $132m More for FDA in 2016

    As House and Senate lawmakers race to approve a bill to fund the US government for 2016, the US Food and Drug Administration (FDA) should see a slight bump in discretionary funding of $132 million over last year. The proposed agreement, which is expected to face a vote on Friday, includes increases of $104.5 million for food safety related activities; $5 million for implementation of the Food and Drug Administration Safety and Innovation Act ( FDASIA ); $8.7 million for ...
  • Regulatory NewsRegulatory News

    FDA Legislation Tracker

    Each year, legislators introduce dozens of pieces of legislation hoping to change how the US Food and Drug Administration (FDA) regulates pharmaceuticals, medical devices, biologics and dietary supplements. Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often. Can't find legislation you know exists...
  • Regulatory NewsRegulatory News

    Congress Eyes Wider Use of Third-Party Medical Device Assessments

    A revised version of the 21st Century Cures Act , a bill being considered by the House Energy and Commerce (E&C) Committee, would allow medical device manufacturers to leverage third-party auditors to assess the state of their quality manufacturing systems. The measure, contained within the "Medical Device Regulatory Process Improvements" section of the bill, was first introduced in the original draft of the 21st Century Cures Act , but was removed without expla...
  • Regulatory NewsRegulatory News

    Marketing Exclusivity Provisions for Rare Disease Drugs Back in 21st Century Cures Bill

    An updated draft of the House Energy and Commerce (E&C) Committee's 21st Century Cures Act has reintroduced a provision which would extend marketing exclusivity for some drugs repurposed to treat rare diseases or conditions by six months. Background The provision, popularly known as the Orphan Product Extensions Now Act , was originally introduced in the US House of Representatives in November 2014. Under the bill, existing pharmaceutical products would be grant...
  • Regulatory NewsRegulatory News

    Legislation Calls for FDA to Ensure Expedited Drugs are Safe for Women

    New legislation introduced last week in the House of Representatives would require greater gender equity in some clinical trials overseen by the US Food and Drug Administration (FDA). The bill, the Research for All Act , was previously introduced in 2014 by Reps. Jim Cooper (D-TN) and Cynthia Loomis (R-WO), and was reintroduced in the House on 29 April 2015. Background At its core, the bill aims to address something long known by regulators and medical research offi...