• 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...
  • Legislators Say FDA Falling Short of Congress' Intent for Medical Gases

    US legislators are calling on the US Food and Drug Administration (FDA) to create a more predictable pathway for innovators and inventors of medical gases, saying the agency's most recent draft guidance document on the subject fails to clarify whether it will guarantee or merely "take into account" a gases' innovative status under an investigational new drug application. Background Medical gases, such as oxygen, nitrous oxide and nitrogen, are most often used alongside ...
  • FDA Seeks Industry Input on Regulatory 'Strategic Plan' to Fight Drug Shortages

    It's been more than a year since the US Food and Drug Administration (FDA) started to make a concerted, large-scale and coordinated effort to combat mounting drug shortages. But now, in response to new statutory requirements contained within the FDA Safety and Innovation Act (FDASIA) , the agency is reaching out to the public in the hopes of learning what more it might be able to do. Background The US has been grappling with a series of mounting drug shortages for the ...
  • FDA Sets Facility Registration Fees for Manufacturers of Generic APIs, Finished Dosage Forms

    • 16 January 2013
    The US Food and Drug Administration (FDA) has published the user fee rates for facilities that manufacture active pharmaceutical ingredients (APIs) and finished dosage forms (FDF) for the current fiscal year, part of the agency's new authority under the FDA Safety and Innovation Act (FDASIA) . In July 2012, FDA was for the first time given the authority to collect user fees from facilities and manufacturers of generic drug products, including those making just the act...
  • Regulatory 'Loophole' Allowing Unsafe Devices to be Marketed, Say Researchers

    • 10 January 2013
    A "loophole" in the way in which some medical devices are regulated is allowing unsafe devices to reach-and harm-patients, argues a new editorial published in the New England Journal of Medicine . The loophole stems from the 1976 Medical Device Amendments , which established for the first time in the US a system for the regulation of medical devices.  The system classified medical devices into three general categories: Class I for low-risk devices, class II for ...