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  • Regulatory NewsRegulatory News

    CBER Director Highlights Firsts in FY2017 Report

    In his second annual report as the director of the US Food Administration's (FDA) Center for Biologics Research and Evaluation(CBER), Peter Marks said the center continued to meet or exceed its performance goals in the final year of the last Prescription Drug User Fee Act (PDUFA V). According to Marks, CBER exceeded its PDUFA goals by completing 100% of its FY2017 cohort of standard and priority biologics license application (BLA) and new drug application (NDA) reviews...
  • 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    Formal Meetings Between FDA and Biopharma Companies: New Draft Guidance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 New draft guidance released last week will help biopharma companies understand how to conduct such meetings and what to expect.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

    Best Practices for IND Sponsor Communications: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) last week finalized guidance from 2015 on the best practices for communications between investigational new drug application (IND) sponsors and FDA. The guidance describes what to expect in milestone meetings (i.e. pre-IND, end-of-Phase 1 and Phase 2 and pre-NDA/BLA [new drug application/biologics license application] meetings) and how sponsors and FDA work collaboratively during the drug development process. In addition, ...
  • Regulatory NewsRegulatory News

    FDA's Frey Reflects on Final Year of PDUFA V

    As the year comes to a close, Patrick Frey, senior advisor to the director of the Office of New Drugs (OND) at the Center for Drug Evaluation and Research (CDER), looked back at FDA's performance over the final year of the fifth iteration of the Prescription Drug User Fee Act (PDUFA V) and what's to come in PDUFA VI. Speaking at the FDA/CMS Summit in Washington, D.C. on Tuesday, Frey said that before PDUFA, and during the first four PDUFA programs, FDA was approving ab...
  • 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    PDUFA VI: FDA Explains User Fee Changes in Draft Guidance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

    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

    Senate to Finish FDA User Fee Reauthorization Bill Ahead of Summer Recess

    Majority Leader Mitch McConnell (R-KY) said Tuesday that the Senate will follow its House counterparts and vote on the US Food and Drug Administration (FDA) user fee reauthorization bill before heading to recess at the end of next week. McConnell called to renew the user fee programs as they are “critical to speeding up the drug approval process, and that’s important for everyone frustrated by the time and cost of bringing lifesaving drugs to market. Without it, ...
  • Regulatory NewsRegulatory News

    House Passes Bill to Reauthorize FDA User Fee Programs

    In a moment of bipartisanship, the US House of Representatives on Wednesday passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022. Several representatives discussed the issue of expensive medicines on the House floor Wednesday, though none of the user fee programs address the issue directly. However, speeding the review of generic drugs could lower some high-priced brand name dr...
  • Regulatory NewsRegulatory News

    House, Senate Still Aim to Pass FDA User Fee Reauthorization Bill Before Delayed August Recess

    The US House of Representatives on Wednesday will take up a bill to reauthorize the US Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee programs, and though the Senate has not yet scheduled a time to take up the bill, it is expected to before thousands of FDA employees are laid off. The bipartisan House user fee bill , which sailed through the Energy & Commerce committee unanimously last month, has be...
  • Regulatory NewsRegulatory News

    HHS Secretary Pushes to Cut FDA Appropriations, Replace With More Industry Fees

    Secretary of Health and Human Services (HHS) Tom Price is continuing to push the Senate to further increase the industry fees paid to the US Food and Drug Administration (FDA), which would upend the agreed-to amounts negotiated by FDA and industry for the next five years, and allow for further cuts to the agency’s congressional appropriations. Last week, the Senate Health, Education, Labor & Pensions (HELP) committee advanced a bill reauthorizing the user fee pro...
  • Feature ArticlesFeature Articles

    FDA User Fee Programs

    This article provides an overview of upcoming important changes to FDA's major user fee programs (PDUFA VI, MDUFA IV and GDUFA II) for Fiscal 2018–2022. It discusses new performance goals, additional commitments FDA has agreed upon with industry and how these changes could impact various types of industry submission strategies. 1-3 Introduction Prior to the passing of the Prescription Drug User Fee Act ( PDUFA ), FDA experienced backlogs in its drug approval proces...
  • Regulatory NewsRegulatory News

    User Fee Reauthorization Bill Amended Ahead of Wednesday Vote

    Ahead of Wednesday’s Senate health committee vote on the five-year reauthorizations of the US Food and Drug Administration (FDA) user fee agreements, the committee has released an updated version of the legislation that includes several medical device bills discussed on the House side. The so-called manager’s amendment of the bill features the same drug, medical device, biosimilar and generic drug user fee agreements crafted over the past two years, as well as ne...