• Regulatory NewsRegulatory News

    Biden’s day one regulatory freeze

    Newly inaugurated President Joe Biden wasted little time in acting to halt former President Donald Trump’s “midnight regulations” and to revoke some of his predecessor’s controversial deregulatory orders in his first day in office.   Biden’s “regulatory freeze” memorandum will likely impact several moves by the Department of Health and Human Services (HHS) in the final days and weeks of the Trump administration that impact the US Food and Drug Administration (FDA), e...
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    White House Commission on Opioids to Trump: Declare a National Emergency

    The White House Commission on Combating Drug Addiction and the Opioid Crisis on Monday urged President Donald Trump to declare the opioid crisis a national emergency under the either the Public Health Service Act or the Stafford Act . In an interim report released Monday afternoon, the commission, chaired by New Jersey Gov. Chris Christie (R),  laid out eight specific actions ahead of a final report to be issued sometime in the future, which will include "a f...
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    White House Doubles Down on Call to Fund FDA Entirely With Industry Fees

    Following the House of Represenatatives' passage of the bill to reauthorize US Food and Drug Administration (FDA) user fees on Wednesday, the White House doubled down on its earlier call to amend the agreements so that FDA is entirely funded by medical products industries. "The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs," the White House said in a statement . "In an era of renewed fiscal restraint,...
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    Trump Administration Officials Huddle at White House to Discuss Drug Pricing

    A White House spokesman confirmed to Focus that a meeting took place at the White House on Friday "as part of the ongoing discussions to reduce the burden of the high cost of drug prescriptions and unleash a wave of innovation to develop cures and treatments for patients." The confirmation follows reports from several media outlets citing sources who say the meeting, with US Food and Drug Administration Commissioner Scott Gottlieb among other officials in atten...
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    GAO: FDA's White Oak Campus Poses Security Risk

    According to a new report from the Government Accountability Office (GAO), parking and cramped offices at the US Food and Drug Administration's (FDA) White Oak campus in Maryland pose a security risk for the agency. In its report, GAO calls on FDA to implement a parking security system in line with the Department of Homeland Security's Interagency Security Committee standards for high risk facilities. The report also calls on the agency to work with the General Services ...
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    Obama: Let's Take Food Regulation out of FDA

    The US Food and Drug Administration (FDA) could stand to lose all of its authority to regulate food products, potentially including dietary supplements, under a new proposal unveiled by President Barack Obama this week. Background The proposal, contained within Obama's budget proposal for fiscal year 2016, would consolidate all regulatory authority for food under a "single new agency within The Department of Health and Human Services," according to the budget. "This ne...
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    How Should Diagnostic Tests be Regulated? Congress Wants to Know

    A new white paper published by the House Energy and Commerce Committee is calling for feedback on the US Food and Drug Administration's (FDA) proposal to regulate laboratory developed tests (LDTs) more similarly to how they regulate in vitro diagnostics. Background Under a longstanding regulatory exemption, lab-developed tests—products developed and used within a single laboratory—have not been subject to FDA’s premarket controls. Instead, the products are subject to th...
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    AHWP Finalizes Document Meant to Form Backbone of Software Regulation Approach

    The medical-device focused Asian Harmonization Working Group (AHWP) has released a new document meant to eventually help provide a common approach for the regulation of medical device software. The draft version of the document was released in July 2014, and provided a high-level overview of the regulatory approaches taken by major economies--the US, EU, Australia and China—toward the regulation of software as a medical device (SaMD). The overall goal of the white pa...
  • FDA Officials are Frequent Visitors to White House, Data Show

    Ever wonder how much influence the US Food and Drug Administration's (FDA) top regulatory officials have with the highest executive office in the land, the White House? If you buy the theory that access is tantamount to influence, the agency seems to have a good amount of it. Focus recently combed through four years of the White House's public visitor logs, querying the data to find instances in which some of FDA's top officials met with the president's staff, either a...
  • CBER to Join Growing Ranks of FDA's Consolidated White Oak Campus

    The US Food and Drug Administration's (FDA) sprawling White Oak campus will soon absorb one of the agency's largest main regulatory divisions, it has announced The White Oak campus , located in Silver Spring, MD, is meant to consolidate all of FDA's headquarter operations in one place. Previously, FDA has offices throughout the Washington, DC metro area, making it difficult for different divisions of FDA to meet with one another in person. Starting in May 2014, FDA's C...
  • AdvaMed Outlines Wishlist for New Changes to 510(k) Process

    The system by which most medical devices reach the market, known as the premarket notification or 510(k) process, has been subject to a considerable amount of criticism in recent years, with detractors claiming that it is both too rigorous and not rigorous enough, and legislators ordering the US Food and Drug Administration (FDA) to scrap planned changes to the process in favor of one yet to be built. Now the influential trade industry group AdvaMed, the largest medical...
  • White House Jumps to Defense of FDA, Other Agencies, over Proposed Budget Cuts

    White House officials are backing up a number of allegations made by several industry watchers regarding the effects of budget sequestration on the US Food and Drug Administration (FDA), noting that, among other things, the cuts could negatively impact drug review times and regulatory science. On 1 March 2013, federal agencies are scheduled to run into the effects of budget sequestration, which calls for annualized budget cuts of approximately 8% for all domestic non-def...