• Regulatory NewsRegulatory News

    Eudamed actor registration module set to launch in December

    In a position paper released Tuesday, the European Commission’s Medical Device Coordination Group (MDCG) confirmed that the Eudamed actor registration module will be deployed on 1 December 2020.   The module was previously expected in May, but its deployment was pushed back by the Commission just before its launch date to reflect the postponed date of application of Eudamed. At the time, the Commission said it would pursue a phased rollout of the six Eudamed modules ...
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    Submitting Manufacturing Facility Information: Final FDA Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized a question and answer guidance on the type of manufacturing facility information that should be included in applications submitted to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. FDA explains that the guidance is meant to help companies understand how not to submit extraneous information or misplaced or missing information that could result in delays, Refu...
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    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(ANDA) holders to submit one-time written reports on whether their products are available for sale or if they have been withdrawn or were never made available for sale.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 ...
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    Formal Meetings Between FDA and Biopharma Companies: New Draft Guidance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 New draft guidance released last week will help biopharma companies understand how to conduct such meetings and what to expect.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...
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    FDA Revises Priority ANDA Draft Guidance

    The US Food and Drug Administration (FDA) on Friday issued a revised version of its draft guidance on the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA). As part of the negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA II), FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a pre-submission facility correspondence (PFC) at leas...
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    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...
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    Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable'

    A generic drug industry group and several companies have taken issue with recent US Food and Drug Administration (FDA) draft guidance on pre-submission facility correspondence (PFC) that spells out what companies need to do to obtain faster abbreviated new drug application (ANDA) reviews. In June, FDA released the draft guidance noting that it is "critical" for there to be a two-month lead time to determine whether facility inspections will be needed for the 8-mon...
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    FDA Details Plans for More Efficient Inspections, Facility Evaluations

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) will soon launch an effort to streamline the two offices' inspection and facility evaluation efforts. In an email to FDA staff on Monday, CDER Director Janet Woodcock and Associate Commissioner for Regulatory Affairs Melinda Plaisier said it is vital that the two offices quickly implement the plan in order to meet commitments under the recent...
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    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...
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    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...
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    Gottlieb: FDA Will Delay Sending Layoff Notices

    In an email to agency staff on Monday, FDA Commissioner Scott Gottlieb said he will delay issuing layoff notices until after 30 September 2017, when the agency's current user fee agreements expire, if Congress has not passed legislation to reauthorize the agreements by then. Previously, FDA has said it would need to begin issuing layoff notices to thousands of employees that are funded by user fees if the agreements are not enacted by 1 August, as agencies are typically ...
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    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...