• 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...
  • Senator Calls--Again--for White House to Release Sunshine Act Rules

    A prominent senator is once again calling upon federal officials to pass a long-delayed rule regarding the transparency of payments made by companies to healthcare providers, saying the delays are "unacceptable." Sen. Charles Grassley (R-IA), is the ranking Republican member of the Senate Committee on the Judiciary, and along with former Sen. Herb Kohl (D-WI) sponsored and wrote the Physician Payments Sunshine Act (Sunshine Act), which eventually became part of the 201...
  • Chinese Firm Used White Out to Change Regulatory Records, FDA Says

    Chinese over-the-counter (OTC) manufacturer Shanghai Huhui Daily Use Chemical Products Company ('Shanghai Huhui') has been blasted by US Food and Drug Administration (FDA) inspectors for allegedly interfering with an investigation of the facility by using white-out on regulatory documents, among other serious alleged violations. The alleged deficiencies are outlined in a 14 November 2012 warning letter to Shanghai Huhui, released to the public on 5 December 2012. In ...
  • Data Exclusivity for Biologics at Forefront of International Trade Agreement Negotiations

    • 08 October 2012
    A host of biopharmaceutical regulatory issues are said to be at the forefront of trade talks between the US and a group of 11 countries in the Asia-Pacific, potentially complicating both the agreement and the Obama administration's already complicated relationship with the pharmaceutical industry, reports Reuters . The agreement in question is known as the Transpacific Partnership (TPP)-a regional trade policy long under negotiation and periodically subject to trans...
  • New Report Calls for Overhaul of Regulatory Processes with Goal of Doubling Drug Approvals by 2027

    A new report released by the President's Council of Advisors on Science and Technology (PCAST) has called for the US Food and Drug Administration (FDA) to approximately double the number of pharmaceutical products it approves each year by the end of 2027. The report, Propelling Innovation in Drug Discovery, Development and Evaluation , comes on the heels of two reports released earlier in 2012 which called for, respectively, a more refined regulatory approach for n...
  • House Releases Previously-unreleased Email Exchanges Between White House, PhRMA

    • 31 May 2012
    A Republican-led investigation into then-secret negotiations between the Obama Administration and the Pharmaceutical Research and Manufacturers of America (PhRMA) has released its preliminary results, consisting of hundreds of pages of internal memoranda and emails between the White House and PhRMA. The investigation has been underway since at least January 2012 when Republican members of the House of Representatives expressed their anger at the Obama Administration appe...
  • White House Wants Agencies to Develop Mobile Technologies, Open APIs

    • 25 May 2012
    A recent memo from the White House to the heads of executive departments and agencies directs them to immediately begin implementation of a new "digital strategy" aimed at making governmental information more readily and easily accessible to citizens and stakeholders. The 23 May memo outlines the government's new information accessibility strategy, contained in an accompanying report entitled, " Digital Government: Building a 21 st Century Platform to Better Serve the A...
  • New Executive Order Directs Agencies to Identify and Reduce 'Regulatory Burdens'

    • 10 May 2012
    The White House has released a new executive order directing federal agencies to identify and reduce "regulatory burdens" in their respective organizations, noting the "challenging economic times" the US is traversing. President Barack Obama's executive order, "Identifying and Reducing Regulatory Burdens", builds upon an existing order by the president ordering agencies to periodically review existing significant regulations and find efficiencies within them. Obama's st...
  • FDA to Delay Implementation Date for Sunscreen Labeling and Testing Changes

    The US Food and Drug Administration (FDA) announced 10 May it will delay implementation of a final rule intended to establish labeling and effectiveness testing for over-the-counter (OTC) sunscreen products, marking the latest development in a long struggle over the regulation of sunscreen products. FDA's final rule establishes new requirements for sunscreen products containing specific active ingredients and marketed without approved applications, "amends labeling claim...
  • New US Bioeconomy Blueprint Addresses Regulatory Hurdles for Drugs, Medical Devices

    The White House Office of Science and Technology (OST) released its National Bioeconomy Blueprint , which charts the course for the future development of bioscience research in the US and addresses numerous regulatory issues. The blueprint is described as a priority of the administration because of the "tremendous potential for growth and job creation." While basic research is an important aspect of the bioeconomy, said OST, regulatory issues are key drivers of ...