• Regulatory NewsRegulatory News

    FDA Kicks Off MDUFA Reauthorization Process

    The US Food and Drug Administration (FDA) is kicking off the reauthorization process for the Medical Device User Fee Act (MDUFA), a program which funds a significant portion of its medical device regulatory review activities. Background FDA's user fee program began with the passage of the Prescription Drug User Fee Act (PDUFA) in 1992. The law, originally intended to speed up the regulatory review process, wound up being so popular that it inspired several other user ...
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    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...
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    Supreme Court Declines to Hear Case on Off-Label Prescribing Authority

    The US Supreme Court has refused to hear a challenge to an Arizona law that sought to limit the use of an abortion drug, avoiding a potential showdown over whether off-label prescribing is explicitly allowed under federal law, or simply tolerated. Background As Regulatory Focus has previously reported , the Supreme Court had been petitioned to hear an appeal of the federal court case  Planned Parenthood v. Humble —a case challenging a 2012 Arizona law which makes i...
  • Feature ArticlesFeature Articles

    US Orphan Drug Exclusivity Criteria Clarified in Depomed Court Decision

    A recent US district court decision could affect US Food and Drug Administration (FDA) interpretation and determinations in the orphan drug exclusivity area. Specifically, on 5 September 2014, the United States District Court for the District of Columbia issued its memorandum opinion in the case of Depomed Inc. v. United States HHS . 1 The case centers on the Orphan Drug Act , which provides incentives to pharmaceutical companies to research and develop drugs for rare ...
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    Off-Label Use Case on Potential Path to Supreme Court, With Wide-Ranging Implications for FDA

    A debate in Arizona which in part focuses on the authority of the US Food and Drug Administration (FDA) to regulate the use of drug products may soon find its way before the Supreme Court, with major implications for a wide range of products. Background The matter in question concerns a federal court case, Planned Parenthood v. Humble , challenging a 2012 Arizona law which makes it illegal to use the drug RU-486 (mifepristone) for uses not explicitly approved by FDA....
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    107 Types of Medical Devices to be Given Regulatory Exemptions Under New FDA Proposal

    The US Food and Drug Administration (FDA) announced Thursday its intent to exempt dozens of medical devices from its premarket notification (also known as 510(k)) regulations. Background During the 2012 negotiation of the Food and Drug Administration Safety and Innovation Act (FDASIA) , FDA committed to proposing (within two years) low-risk medical devices which could be exempted from premarket notification. ( See FDA's Commitment Letter here ) But what does F...
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    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...
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    Medical Device User Fees Set to Drop in 2015, But Not by Much

    The US Food and Drug Administration (FDA) has announced the fees it plans to charge manufacturers of medical device products in Fiscal Year (FY) 2015 under the Medical Device User Fee (MDUFA) program. The fees, which were updated in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) , are collected by FDA and used to hire additional review staff and make other improvements at the agency meant to speed up device review times. Under FDASIA , ...
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    FDA-Commissioned Report Makes Major Recommendations on How to Improve CDRH

    US medical device regulators should make several major changes to ensure that they are able to regulate products more quickly, efficiently and predictably, a new report commissioned under the Food and Drug Administration Safety and Innovation Act (FDASIA) says. Background The medical device industry has often lambasted the US Food and Drug Administration's review process as being increasingly  onerous, slow and unpredictable —a view also  shared  by government i...
  • Legislators to OMB: Sequestration of FDA User Fees Wrong, Should be Reversed

    Legislators in the House of Representatives seem to have a consistent message for the White House's Office of Management and Budget (OMB), the office which effectively sets and enforces policy within the executive branch: Stop holding the US Food and Drug Administration's (FDA) user fees hostage. Background FDA's funding comes from a variety of different streams. While it receives a substantial amount of funding from the congressional appropriations process, it also rec...
  • CDRH Says Dozens of Applications Affected During Shutdown, and Residual Delays Likely

    The US' political system has seen better days, as evidenced by the recent shutdown of many government services after legislators failed to pass a budget by 1 October 2013. For the US Food and Drug Administration (FDA), which is funded through a mix of appropriated funding and industry-paid user fees, this also meant a lapse in its statutory authority to collect or spend new user fees. And as a recent email sent to the medical device industry indicates, that will result i...
  • FDA Issues Guidance on Qualifying for Device User Fee Exemptions, Reductions

    Last week, the US Food and Drug Administration (FDA) released all of the updated user fees various regulated industries will need to pay to the agency in the coming 2014 fiscal year, including special exemptions for some medical device companies. Now FDA is out with a new guidance document meant to explain exactly which medical device companies are eligible for reduced rates, and how to determine eligibility. Background Since the Medical Device User Fee Act (MDUFA) ...