• FDA Gears up to Tackle Problem of Underrepresented Populations in Clinical Trials

    When the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in 2012, among its many provisions was one not noticed by many: Section 907. The section requires FDA,  within one year of the law's passage, to publish a report "addressing the extent to which clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups-including sex, age, race and ethnicity-is included in [product] applications ...
  • As FDASIA Celebrates First Year, FDA Says Drugs, Devices Already Seeing Benefit

    On 9 July 2012, US President Barack Obama quietly signed into law a piece of legislation that had received overwhelming support in both chambers of Congress - a relative rarity in the hyper-political 112 th Congress. That law, the Food and Drug Administration Safety and Innovation Act (FDASIA) , is now one year old, and the US Food and Drug Administration (FDA) is marking the occasion by talking about what it's been doing to implement the considerable number of provisio...
  • FDA Wants Input on Quality Inspection, Import Procedures Under FDASIA

    When US legislators and President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in July 2012, they did so - among other reasons - in the hope that provisions within the bill would help protect the supply chain for pharmaceutical products, which are increasingly being made and manufactured outside US shores. Now the US Food and Drug Administration (FDA) is looking to actualize those hopes, announcing a public meeting and...
  • FDA's Antibacterial Task Force Takes Shape, Seeks Ideas on How to Support New Guidance, Paradigms

    US regulators are once again reaching out to members of industry, this time seeking input on how the US Food and Drug Administration (FDA) facilitates the development of new antibiotics, and whether it could be doing more to help the pharmaceutical industry stay ahead of rising rates of antibiotic resistance. Background "Antibacterial drug development is critical to the public health and is an FDA priority," FDA explains in a new Federal Register posting. "We recogniz...
  • FDA Looking to Improve the Generic Drug Regulatory Process, Wants Industry Input

    The US Food and Drug Administration (FDA) plans to hold a public meeting in June 2013 to discuss its progress in advancing regulatory science for generic drug products and solicit feedback on its research priorities as it looks to fulfill its statutory goals under the FDA Safety and Innovation Act (FDASIA) . Background In July 2012, FDASIA -a massive piece of legislation containing numerous FDA reform provisions and user fee bills-was passed into law, and with it the ...
  • IBM Awarded Huge Contract to Modernize Regulatory Review Processes at FDA

    The US Food and Drug Administration (FDA) has awarded a massive new contract to contractor International Business Machines (IBM) to help the agency improve its ability to review and analyze regulatory submissions the agency receives from pharmaceutical, medical device and biologic manufacturers. Background FDA first published a request for a proposal in July 2012, explaining that it was "seeking strategic and operational planning and other technical and user support, ...
  • All Generic Facilities Must Re-Register With FDA Starting Next Month, Agency Says

    The US Food and Drug Administration (FDA) has announced a self-identification reporting period for the generic pharmaceutical industry during the upcoming fiscal year (FY), part of new requirements established under the FDA Safety and Innovation Act's (FDASIA) generic drug user fee provisions. Background In the lead-up to the 2012 passage of FDASIA , FDA's regulators had a problem: Increasing trends in globalization had resulted in many manufacturers of generic drugs...
  • FDA Seeks New Authority Through FDASIA to Administratively Detain Deficient Pharmaceuticals

    The US Food and Drug Administration (FDA) has announced that it will begin to solicit comments from industry and the public regarding a pending regulation that would expand its authority to administratively detain deficient pharmaceutical products. Background The provision, found under 304(g) of the Federal Food Drug and Cosmetic Act (FD&C Act) , has historically allowed FDA to detain two types of products if the agency suspects they are adulterated or misbranded...
  • New FDA Guidance Clarifies Process for Submission of Device User Fees

    A new guidance document published by the US Food and Drug Administration (FDA) establishes and otherwise clarifies the process by which biopharmaceutical and medical device companies need to pay user fees to the agency in return for the processing of their premarket approval (PMA) applications and device biologics license applications (BLAs). Background In July 2012, President Barack Obama signed into law the FDA Safety and Innovation Act (FDASIA) , which, among other ...
  • PhRMA, GPhA Call for Revival of Pharmaceutical Track and Trace Measures

    The 2012 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) was remarkable for both the number of reform provisions contained within it and the overwhelming support it received in the US Congress. But that support was not earned without some hard negotiating, and several prominent but controversial provisions were dropped from the final iterations of the bill. Now some of the industry's most prominent voices are taking to the Washington press...
  • FDA Authorized to Spend New User Fees Under Just-Passed Senate Bill

    The US Senate has approved  a measure that would both continue funding government agencies at their currently-appropriated levels and grant the US Food and Drug Administration (FDA) access to user fees it is already authorized to collect, raising the possibility that US regulators will soon be given access to much-needed funding. The bill, known as the continuing resolution (CR), is needed to prevent a potential government shutdown that will otherwise occur at the ...
  • Legislation Corrects User Fee Oversight for Medical Devices, Generic Drugs

    Legislators have introduced a piece of legislation in the US House of Representatives that would allow the US Food and Drug Administration (FDA) to spend user fees that it had previously been able to collect, but unable to spend. The appropriations bill, introduced on 4 March 2013 by Rep. Hal Rogers, chairman of the House Appropriations Committee, would fund the government to the tune of $982 billion through 30 September 2013, when-in theory-legislators should be able to...