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  • Regulatory NewsRegulatory News

    One-Time Marketing Status Reports Due in February, FDA Says

    The US Food and Drug Administration (FDA) is calling on all new drug application (NDA) and abbreviated new drug application (ANDA) holders to submit one-time written reports on whether their products are available for sale or if they have been withdrawn or were never made available for sale. Reports are due 14 February and are required under a provision from the law reauthorizing the user fee programs. "The NDA or ANDA holder can submit the one-time report to FDA ...
  • Regulatory NewsRegulatory News

    Formal Meetings Between FDA and Biopharma Companies: New Draft Guidance

    Know the difference between a Type A, Type B and Type C meeting with the US Food and Drug Administration (FDA)? New draft guidance released last week will help biopharma companies understand how to conduct such meetings and what to expect. The 20-page draft explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/videoconference meetings or written responses only, what sponsors should include in that request, how F...
  • Regulatory NewsRegulatory News

    FDA Describes New GDUFA II User Fee Structure

    The US Food and Drug Administration (FDA) on Friday issued a draft guidance describing the new fee structure and types of fees applicable to generic drugmakers under the recently reauthorized Generic Drug User Fee Amendments (GDUFA II). Specifically, the guidance provides details on the various types of user fees under GDUFA II, how companies can pay those fees, the consequences of not paying and who is responsible for paying them. The guidance also provides informatio...
  • Regulatory NewsRegulatory News

    PDUFA VI: FDA Explains User Fee Changes in Draft Guidance

    The US Food and Drug Administration (FDA) has begun implementing the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and on Thursday released draft guidance explaining the new fee structure and types of fees for which industry is responsible. Changes to the fee structure under PDUFA VI mean FDA can collect two types of fees through 2022: human drug application fees (accounting for 20% of the total), collected at the time applications are submitted, and pres...
  • Regulatory NewsRegulatory News

    HHS Inspector General Finds FDA Spends User Fees Appropriately

    The US Department of Health and Human Services’ (HHS) Office of Inspector General on Thursday released a report finding that the Food and Drug Administration (FDA) generally spent prescription drug user fees appropriately. Background FDA is authorized to collect user fees from pharmaceutical and biotechnology companies seeking approval of certain human drug and biological products to expedite the review of applications. Congress reauthorizes the user fee agreem...
  • Regulatory NewsRegulatory News

    FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions

    The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV). In its MDUFA IV commitments, FDA agreed to tighter timelines to reach decisions for most medical device submissions in exchange for increased user fees and the introduction of a n...
  • Regulatory NewsRegulatory News

    FDA Unveils Higher PDUFA, Lower BsUFA Fees for FY 2018

    With the new user fee deals signed into law, the US Food and Drug Administration (FDA) on Wednesday unveiled the revamped fee amounts that will apply from 1 October 2017 to 30 September 2018 for prescription drug and biosimilar application and programs. For prescription drugs requiring clinical data, the price for FY 2018 will be about $2.4 million, which is nearly $400,000 more than in 2017. For prescription drugs not requiring clinical data, the fee will be about...
  • Regulatory NewsRegulatory News

    Congress Takes First Look at User Fee Program for OTC Drugs

    The House Energy & Commerce committee on Wednesday held its first hearing on a bill to reform the US Food and Drug Administration's (FDA) over-the-counter (OTC) drug monograph process by creating a new user fee program and offering marketing exclusivity for innovations to monograph products. A bipartisan discuss draft of the bill, developed by Reps. Bob Latta (R-OH), Diana DeGette (D-CO), Brett Guthrie (R-KY), Debbie Dingell (D-MI), Gene Green (D-TX) and Subcommittee o...
  • Regulatory NewsRegulatory News

    Some FDA Medical Device, Generic Drug User Fees Spike in FY 2018

    Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) and Medical Device User Fee Amendments of 2017 (MDUFA IV), the US Food and Drug Administration (FDA) will collect significantly higher user fees for some applications than in recent years though how the fees are calculated has been restructured under the two new agreements. For instance, device companies submitting 510(k) applications, which are for devices equivalent to ones already marketed, fees wi...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022

    President Donald Trump late Friday signed a bill that reauthorizes the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, biosimilars and medical devices through 2022. Taking effect 1 October, the 86-page law (the text of which can be found here ) passed the House via voice vote in July and by a vote of 94-1 in the Senate earlier this month without the addition of any controversial amendments. The law ensures the ag...
  • Regulatory NewsRegulatory News

    Trump to Sign FDA User Fee Reauthorization Bill

    Ahead of its summer recess, the US Senate on Thursday followed its House counterparts and passed a bipartisan bill to reauthorize the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years. A spokesman for President Donald Trump told Focus , “The President will sign this bill, but we look forward to working with Congress to address further negotiations.” The Senate’s pas...
  • Regulatory NewsRegulatory News

    FDA Details Draft Goals for OTC Monograph User Fee Program

    After a series of discussions with industry and a public meeting in June 2016, the US Food and Drug Administration (FDA) last week released its draft goals letter for the proposed over-the-counter (OTC) monograph user fee program. The agency also announced on Tuesday that it will host a webinar to provide an overview of the proposed program to stakeholders on 23 August 2017. OTC Monograph User Fees Dubbed OMUFA, short for the yet-to-be introduced Over-the-Counter M...