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  • Feature ArticlesFeature Articles

    The Prescription Drug User Fee Act (PDUFA): A Primer

    This article discusses key points and benefits of the Prescription Drug User Fee Act (PDUFA) for those filing a New Drug Application (NDA) and explains how PDUFA user fees have played an important role in expediting FDA's drug approval process. Introduction: Benefits Offered by PDUFA When planning a New Drug Application (NDA) or other type of marketing application, regulatory professionals must consider many things. These considerations include: when the data will com...
  • Regulatory NewsRegulatory News

    PhRMA Seeks More Transparency on FDA Inspections to Speed First-Cycle Approvals

    The Pharmaceutical Research and Manufacturers of America (PhRMA) last week said it supports the US Food and Drug Administration's (FDA) review of its inspection information flow, particularly as applications that receive on-time inspections typically receive first cycle approvals earlier. The comments were made in response to FDA's assessment of its program for enhanced review transparency and communication for new molecular entity new drug applications (NME NDAs) and or...
  • Regulatory NewsRegulatory News

    Failure to Reauthorize User Fee Programs Would Result in About 3,000 FDA Layoffs

    Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions on Tuesday that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration (FDA) would likely see more than 3,000 job cuts. Those layoffs, if Congress and President Donald Trump fail to act before 1 August or Congress’ summer recess, would significantly curtail new medical product...
  • Regulatory NewsRegulatory News

    Woodcock, Industry Groups Tell House E&C Committee PDUFA Reauthorization Delays Could be Dire

    Leaders from the biopharmaceutical industry lobby and a patient advocacy group on Wednesday urged members of the House Energy and Commerce Committee to reauthorize the sixth iteration of the Prescription Drug User Fee Act ( PDUFA VI). And, in her second straight day of testimony on user fees before Congress, Janet Woodcock, director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) detailed how the agency's ability to...
  • Regulatory NewsRegulatory News

    CDER, CDRH and CBER Directors Stress Importance of User Fee Reauthorizations Before Senate Committee

    The US Senate Health, Education, Labor & Pensions Committee on Tuesday pressed three top US Food and Drug Administration (FDA) officials for details on how plans to reauthorize their user fee programs would help to further streamline medical product approvals. All three officials highlighted the past successes of the user fee programs, and overall, it did not seem as though user fee goals letters would be reworked or that further negotiations would be needed before the b...
  • Regulatory NewsRegulatory News

    FDA to Discuss Autism and Available Treatments in May

    An upcoming public meeting is intended to allow the US Food and Drug Administration (FDA) to obtain patient perspectives on the impact of autism on daily life, as well as views on treatment approaches. Background As part of commitments tied to the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V), under Title I of the Food and Drug Administration Safety and Innovation Act , FDA has selected autism as the focus of a public meeting on 4 May 2017, fr...
  • Regulatory NewsRegulatory News

    GOP Sets June Deadline for Completing FDA User Fee Reauthorizations

    Republicans have set a deadline of June to complete the Congressional work on reauthorizing the US Food and Drug Administration’s (FDA) user fee programs. The setting of the deadline, according to a document obtained by Politico, comes as FDA staff and Congressional staff have recently cancelled meetings to work on the reauthorizations of the Prescription Drug User Fee Act (PDUFA VI), the Medical Device User Fee Act (MDUFA IV), the Generic Drug User Fee Act (G...
  • Regulatory NewsRegulatory News

    CBER Director Touts Center's FY2016 Performance

    The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) has once again met or exceeded its performance goals for reviewing and acting on product applications and supplements, according to a report released Thursday from CBER Director Peter Marks. The report is Marks' first since he rose to head CBER last January, replacing former CBER Director Karen Midthun after her 22-year stint at the agency. As in previous years, CBER met or e...
  • Regulatory NewsRegulatory News

    BIO Exec Worries User Fee Agreements Could See Setbacks Under Trump

    The already agreed-to user fee agreements between FDA and industry could face setbacks under the incoming Trump administration. Speaking at the FDA/CMS Summit in Washington, DC last week, Kay Holcombe, senior vice president for science policy at the Biotechnology Innovation Organization (BIO), said she's concerned that the user fee agreements, which were negotiated under the Obama Administration, will be reviewed by a new Congress and new administration, each of which mi...
  • Regulatory NewsRegulatory News

    'Cures,' User Fees and Automation: Woodcock Details Priorities and Challenges for 2017

    The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday at the FDA/CMS Summit in Washington, DC, that she's looking to develop a plan to automate processes for new drug reviews, implement provisions of the 21st Century Cures Act and support the reauthorization of the user fee acts in 2017. 21st Century Cures On Tuesday, President Obama signed the 21st Century Cures Act into law, ushering forth...
  • Regulatory NewsRegulatory News

    PhRMA and BIO Offer Glowing Support for PDUFA VI Performance Goals

    More than a year after the pharmaceutical and biotech trade groups began voicing their opinions and crafting the next iteration of the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA), and both PhRMA and BIO have said they are pleased with the performance goals outlined by and for the agency from 2018 to 2022. Background On 15 July, the US Food and Drug Administration (FDA) released for comment a  46-page document  outlining how the agency ...
  • Regulatory NewsRegulatory News

    PDUFA Reauthorization: AstraZeneca Offers Detailed Recommendations

    Although the performance and procedural goals for the sixth iteration of the Prescription Drug User Fee Act (PDUFA ) were laid out last month, pharmaceutical companies, including AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the program from fiscal years 2018 through 2022. Background On 15 July, the US Food and Drug Administration (FDA) released for comment a 46-page document outlining how the agency will use t...