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  • Regulatory NewsRegulatory News

    FDA FY2021 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program:   FDA User Fee Table FY2021 Prescription Drug User Fee Act (PDUFA VI) FY2021 FY2020 Change Applications:            Requiring clinical data $2,875,842 $2,942,965 -$67,123 ...
  • Regulatory NewsRegulatory News

    EMA Fees See 1.7% Increase

    From Monday, all general fees payable to the European Medicines Agency (EMA) will be subject to a 1.7% increase compared to those received by 31 March, as part of alignment with the EU’s 2018 inflation rate. The 1.7% increase applies to applicants’ and marketing authorization holders’ general fees payable to EMA. It brings the previous basic fee of €286,900 ($321,774) up to €291,800 ($327,269) on a new application for which the presentation of a full dossier is needed, ...
  • Regulatory NewsRegulatory News

    EMA Announces Pharmacovigilance Fee Increase

    Pharmacovigilance fees payable to the European Medicines Agency (EMA) were increased by 1.7% on Thursday to account for inflation in 2017.   Pharmacovigilance fees in in the EU are set by Regulation (EU) No 658/2014, which includes provisions for the European Commission to adjust the fees to keep up with the rate of inflation as measured by the European Index of Consumer prices.   The increased fee rate was established under Commissioner Delegated Regulation (EU)...
  • Regulatory NewsRegulatory News

    EMA: Pharmacovigilance Fees to Rise in 2018

    The European Medicines Agency (EMA) on Wednesday said it expects fees paid by drugmakers for pharmacovigilance applications to rise by 1.4% in mid-January 2018. Pharmacovigilance fees in in the EU are set by Regulation (EU) No 658/2014 , which includes provisions for the European Commission to adjust the fees to keep up with the rate of inflation as measured by the European Index of Consumer prices. Due to a low level of inflation in 2015 (0.2%), the Commission in 20...
  • 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    The US Food and Drug Administration (FDA) on Friday issued a draft guidance describing the new fee structure and types of fees applicable to generic drugmakers under the recently reauthorized Generic Drug User Fee Amendments (GDUFA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

    Health Canada Seeks to Update User Fees for Drug and Device Firms

    Health Canada this week opened for consultation a proposal to update and increase some of the fees it assesses for pharmaceutical and medical device companies, noting that the last update came in 2011 and was based on 2007 data. In addition to increasing some fees significantly (see more below on some of the changes), the proposal would also give new authority to Health Canada to withdraw or withhold service or approval if a fee is not paid, and all fees moving fo...
  • 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...