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  • Regulatory NewsRegulatory News

    FDA Unveils User Fee Rates for FY2016

    In the 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, but for FDA itself. The problem, FDA argued, was that the agency lacked adequate funding to hire the staff it needed to review drugs in a more timely manner. The solution FDA proposed was to collect one-time fees from the companies it regulates...
  • Regulatory NewsRegulatory News

    Legislators Want to Exempt Much of FDA's Funding from Future Budget Cuts

    New legislation introduced in Congress would exempt nearly half of the US Food and Drug Administration's (FDA) budget from austerity measures meant to help balance the federal budget. Background The bill, the FDA Safety Over Sequestration (FDA SOS) Act would specifically exempt FDA's user fees from the effects of future budget sequestration . The user fees, which come from the pharmaceutical and medical device industries, are meant to help fund FDA's regulatory...
  • Regulatory NewsRegulatory News

    FDA Announces all User Fees to be Paid by Pharma, Device Industries in 2015

    The US Food and Drug Administration (FDA) has now released all user fee amounts for the coming 2015 Fiscal Year, including fees for medical devices, pharmaceuticals, generic drugs, biosimilar drugs, drugs compounded at outsourcing facilities, animal drugs and generic animal drugs. The current FY 2014 user fees are also displayed, as are fees from FY 2013, when most programs were overhauled under the Food and Drug Administration Safety and Innovation Act (FDASIA) . Thi...
  • FDA Publishes All User Fee Rates for Fiscal Year 2014

    The US Food and Drug Administration (FDA) has just published the user fee rates set to go into effect for the coming 2014 fiscal year (FY), including those for pharmaceuticals, biosimilars, facilities, master files, generic drugs and medical devices. Background Since the early 1990s, FDA has become increasingly reliant upon user fees to fund its operations. Whereas before the agency relied almost entirely on federal funding to conduct its operations, now nearly all indu...
  • Obama Signs New FDA User Fee Bill for Veterinary Pharmaceuticals Into Law

    US President Barack Obama has signed into law a new piece of legislation that is set to increase the amount of funding given to the US Food and Drug Administration (FDA) by the veterinary pharmaceutical industry in the hopes of speeding up review and clearance times for product applications. Background The legislation, known as the  Animal Drug and Animal Generic Drug User Fee Reauthorization Act (ADAGDUFRA) , is an amalgamation of the Animal Drug User Fee A...
  • Veterinary User Fee Bills Pass Congress, Await Obama's Signature

    US legislators in the House of Representatives this week announced the passage of a package of user fees that would enhance what the US Food and Drug Administration (FDA) collects from members of the veterinary pharmaceutical industry. Background Passage of the legislation was in many ways overshadowed by the debate over and passage of another major piece of legislation that would reform security standards for the pharmaceutical industry, known as the Safeguarding Am...
  • Veterinary User Fee Bills Move Forward in Congress as Approval Appears Likely

    Congressional legislators have nearly cleared a new piece of legislation that would reauthorize the US Food and Drug Administration (FDA) to collect and spend user fees to facilitate and expedite the approval of innovative and generic veterinary pharmaceuticals. Background The bills, the  Animal Drug User Fee Act (ADUFA)  and the  Animal Generic Drug User Fee Act (AGDUFA) , are, like their human prescription drug and medical device counterparts, a me...
  • Legislators Reveal Text of Veterinary User Fee Bills, Free from Potential Markups

    • 08 April 2013
    • By
    US legislators on the House of Representatives' Energy and Commerce Committee have finally released the draft versions of two bills that would serve to reauthorize industry-paid user fees for both innovative and generic veterinary medicines. Background The bills, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) , are, like their human prescription drug and medical device counterparts, a mechanism by which the veterinary pharmace...
  • Following FDASIA, Veterinary User Fee Bills Prepare for Congressional Scrutiny

    Congress has begun the process of taking up two bills that stand to make reforms to the user fee process for innovative and generic veterinary pharmaceutical products with the stated goals of generating faster approval times for products while providing better funding sources for the US Food and Drug Administration (FDA). Background The bills, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) , are similar in nature to an omnibus ...
  • Group Sues FDA, Seeking 'Confidential Information' About Antibiotic Prescribing Data

    • 06 December 2012
    • By
    A consumer advocacy group has filed a lawsuit against the US Food and Drug Administration (FDA) for withholding data regarding the use and sale of antibiotics used in food-producing animals, saying the denial of its Freedom of Information Act (FOIA) request for the information was "unlawful." The group, the Government Accountability Project (GAP), which bills itself as a whistleblower protection organization, said it objects to FDA withholding certain data reported to ...
  • FDA Launches Renewal Process for Animal Drug User Fees With New Proposals

    • 04 December 2012
    • By
    The US Food and Drug Administration (FDA) is preparing for two meetings on both branded and generic veterinary pharmaceutical products, part of the impending renewal of two user fee acts meant to fund the agency's reviews and other regulatory activities in return for more accountability. The two user fee bills-the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) -act in much the same way as those for human prescription drug products, med...
  • Proposed Changes to Antibiotic Regulation Given More Time for Public Comment

    The US Food and Drug Administration (FDA) has extended the amount of time the public and members of industry may comment on an advanced notice of public rulemaking concerning proposed changes to the way the agency collects and tracks information about antibiotics. The regulation regards authority given to the agency under the Animal Drug User Fee Amendments Act of 2008 ( AGDUFA ), which allows FDA to require sponsors to submit annual reports detailing sales, distributi...