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  • Regulatory NewsRegulatory News

    PDUFA VI: Highlights on What to Expect

    The US Food and Drug Administration (FDA) and stakeholders from industry and patient groups on Monday outlined the agreement they forged on the next reauthorization of the Prescription Drug User Fee Act (PDUFA) that begins in 2017, focusing on what’s to come on pre-market reviews, postmarket safety, regulatory decision tools and other ways FDA is preparing for the future of drug development. The meeting follows the July release of the full details of the performance ...
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    FDA Unveils User Fee Rates for FY 2017

    In the late 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, but for the US Food and Drug Administration (FDA) itself. The problem, FDA argued, was that the agency lacked adequate funding to hire the staff it needed to review drugs in a timely manner. The solution FDA proposed was to collect fees fr...
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    Prescription Drug and Biosimilar User Fees to See Major Discounts in 2017

    As an increasing number of new drug applications (NDAs) and biologic license applications (BLAs) are expected to be submitted in 2017, the US Food and Drug Administration (FDA) has lowered some of the application fees by more than $300,000. For 2017, the fee for an NDA requiring clinical data or a biosimilar application requiring clinical data will be $2,038,100, which is $336,100 less than the $2.37 million fee from 2016 . For an NDA not requiring clinical data or a ...
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    The Next PDUFA: New Performance and Procedural Goals

    Exactly one year after the first round of negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA), the US Food and Drug Administration (FDA) on Friday released the full details of the performance and procedural goals for fiscal years 2018 through 2022. The 46-page document, which outlines how the agency will use the user fees provided to it from industry, breaks down not only the planned deadlines for new guidance documents and pilot projec...
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    Pharma Companies: FDA Wants New Info for FY2017 User Fees

    The US Food and Drug Administration (FDA) is reminding pharmaceutical companies that they have until 10 June 2016 to submit information FDA needs to prepare invoices for the upcoming fiscal year. The reminder, which comes in the form of a "Dear Colleague" letter sent to drugmakers earlier this month, instructs companies to complete two attachments to inform the agency of any of a company's products and establishments that are subject to user fees. Under the Prescription...
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    PDUFA VI Reauthorization: Industry, FDA Discuss Broader Use of Real World Evidence

    Representatives from industry groups BIO and PhRMA met with officials from the US Food and Drug Administration (FDA) twice last month to discuss new plans for using real world evidence to support benefit-risk assessments for medical products, according to the meeting minutes of a subgroup of the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA). Background Congress created the Prescription Drug User Fee Act (PDUFA) in 1992 to help FDA collect fees from...
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    FDA Raises Fee Rate for FY16 Tropical Disease Priority Reviews

    The US Food and Drug Administration (FDA) has raised the tropical disease priority review fee rate for fiscal year 2016 to about $2.73 million, which is effective from the beginning of next month through 30 Sept, 2016. The new rate is about $200,000 more than last year's rate , but more than $2m less than the rate for fiscal year 2012. Back in 2008, FDA issued guidance for industry on tropical disease priority review, detailing the way in which the vouchers can be sol...
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    FDA Unveils User Fee Rates for FY2016

    In the 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, but for FDA itself. The problem, FDA argued, was that the agency lacked adequate funding to hire the staff it needed to review drugs in a more timely manner. The solution FDA proposed was to collect one-time fees from the companies it regulates...
  • Regulatory NewsRegulatory News

    PDUFA VI: FDA Hears Stakeholder Comments in First Public Meeting

    The US Food and Drug Administration (FDA) today heard from various groups representing patients, healthcare professionals and the regulated industry for their input on the iteration of the Prescription Drug User Fee Act (PDUFA). Background In the 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, b...
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    FDA Kicks off Reauthorization Process for PDUFA

    The US Food and Drug Administration (FDA) has announced the start of the next reauthorization process for the Prescription Drug User Fee Act (PDUFA), a major framework under which most new drug products in the US are reviewed. Background PDUFA was first authorized in 1992, and has since been reauthorized four times, most recently in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) . As with FDA's other user fee programs, PDUFA is based o...
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    FDA Approving Most New Drugs and Biologics During Their First Review, Report Finds

    The US Food and Drug Administration's (FDA) is now approving more new drugs and biologics during their first review cycles than at any time since at least 2008, a new FDA-commissioned report shows. Background The report , conducted by the Eastern Research Group (ERG) on behalf of FDA, is focused on the fifth iteration of the Prescription Drug User Fee Act (PDUFA) , which was passed in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) . P...
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    Meeting With FDA? Here's What Regulators do (and Don't) Want from Drug Companies

    A new guidance document issued by the US Food and Drug Administration (FDA) is meant to outline the agency's expectations for meetings that take place between FDA and a sponsor before and after the submission of a new chemical or biological drug product. Background Since the passage of the original Prescription Drug User Fee Act (PDUFA) in 1992, the pharmaceutical and biopharmaceutical industries have helped to fund the operations of FDA through payments of so-called ...