• Regulatory NewsRegulatory News

    House Appropriators Target Areas for FDA Improvement

    The House Appropriations Committee on Tuesday voted to send its FY 2020 spending bill for the US Food and Drug Administration (FDA) to the House floor, in addition to releasing a report explaining areas where FDA needs to focus its efforts. The funding bill would provide FDA with $3.26 billion in non-user fee funding, an increase of $184 million (6%) above the FY 2019 enacted level. According to the Alliance for a Stronger FDA, the bill is expected to be taken up on the...
  • 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

    ICH Transparency: New Info on Funding, Expert Working Groups

    The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded. "While these experts represent the regulatory and industry association parties that nominate them, this new level of transparency will bring a novel understanding of who contributes to the development of guidelines as well as the roles they play," ICH said. Accord...
  • 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

    Senate Pushes Work on ‘Cures’ Legislation Back to September

    The Senate’s version of the House-passed 21st Century Cures bill will not be finished until after the Senate’s summer recess, or September at the earliest, Sen. Lamar Alexander (R-TN) said, confirming rumors that the Senate was struggling to reach agreement on the wide-ranging and heavily criticized legislation. “Rarely do we have such an opportunity: it includes support for the President’s Precision Medicine initiative and the Vice President’s Cancer Moonshot. Speaker [...
  • Regulatory NewsRegulatory News

    Senate Advances $1.1B in Emergency Zika Funds as House Fight Looms

    The Senate on Tuesday voted in favor of providing $1.1 billion in new funds to fight the Zika virus, which continues to spread in Central and South America and is expected to hit the US soon. The 68-29 vote in the Senate means the new funding could be added to an unrelated spending bill, though the funds are significantly less than the $1.9 billion President Barack Obama and the National Institutes of Health (NIH) requested three months ago to fight Zika. The Senate vot...
  • Regulatory NewsRegulatory News

    Cash-Strapped MHRA Looks to Stay Flexible

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released its business plan for 2016-17, warning of serious financial troubles, particularly as funding for the regulation of medical devices has declined over the past decade and as it's losing revenue from industry because of changes at the EU level. “Funding for devices regulation is at half the level of what it was in 2003 in real terms; and while a number of efficiency measures have been t...
  • Regulatory NewsRegulatory News

    Additional Funding to Combat Zika Denied in House Markup of FDA Spending Bill

    The House Appropriations Committee on Tuesday marked up the FY 2017 spending bill for the US Food and Drug Administration (FDA) and decided not to include an amendment adding $1.9 billion in additional funding requested by President Barack Obama to combat the Zika virus. Republicans argued that Obama did not provide enough specifics on where the funds will go and they voted against Rep. Nita Lowey’s (D-NY) amendment that would have attached the Administration’s additiona...
  • Regulatory NewsRegulatory News

    Senate Democrats Call for FDA, NIH Funding Boost as Other Bills Emerge

    Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) on Thursday introduced a bill that would provide $5 billion per year in new funding for the Food and Drug Administration (FDA) and National Institutes of Health (NIH). The boost in funds for FDA and NIH, backed by the Health, Education, Labor & Pensions (HELP) Committee Democrats, comes almost a month after the committee, still looking to pass companion legislation to the House-passed 21st Century Cures bill , advan...
  • Regulatory NewsRegulatory News

    Trying to Treat or Cure a Rare Animal Disease? FDA Says it Wants to Help

    Have an idea for a new animal drug intended to help treat a rare disease in animals or an unusual creature? The US Food and Drug Administration (FDA) says it may have some funding for you. Background The money relates to a little-known regulatory designation established under the Minor Use and Minor Species Animal Health Act (MUMS Act) of 2004. Under the law, animal conditions are effectively treated as rare if they meet either of two conditions: If the condition a...
  • Regulatory NewsRegulatory News

    FDA to Put $2.5M Behind Kidney Initiative Meant to Optimize Drug Development

    US regulators say they're planning to award at least $500,000, and as much as $2.5 million, to a set of initiatives meant to improve the regulator's understanding of the effects of pharmaceutical products on the kidney. In a Federal Register notice issued on 9 June 2014, FDA said its Center for Drug Evaluation and Research (CDER) plans to award a one-year, $500,000 contract to the American Society of Nephrology (ASN) to support the regulator's Kidney Health Initi...
  • Regulatory NewsRegulatory News

    FDA Plans to Spend as Much as $50M on Regulatory Science, With Focus on Generics

    The US Food and Drug Administration (FDA) has released its latest " Broad Agency Announcement " detailing the areas to which it hopes to direct funding in the coming year in order to solve or alleviate some of its most pressing regulatory needs. Like FDA's 2013 Broad Agency Announcement, the 2014 announcement says FDA is prepared to spend—"subject to congressional appropriations"—as much as $50 million on meeting nine overarching goals and dozens of sub-level interests. ...