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  • Regulatory NewsRegulatory News

    FDA Pushes Back eCTD Deadline for Type III DMFs Again

    Ahead of the 5 May 2019 deadline set last April, as the required date for Type III drug master file (DMF) submissions in electronic common technical document (eCTD) format, the US Food and Drug Administration revised final guidance to reflect a new one-year delay on the implementation date. The sixth version of the final guidance for compliance with eCTD requirements was posted Tuesday to push the date back again after version 5 provided an extension from the previous...
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    Asia Regulatory Roundup: TGA Adopts Guidance on Device Priority Review Pathway (2 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Adopts Guidance on Medical Device Priority Review Pathway Australia’s Therapeutic Goods Administration (TGA) has adopted guidance on its priority review pathway for medical devices. The adoption of the guidance allows developers of highly promising devices aimed at serious unmet needs to jump to the front of the queue when they file for approval. Devices must mee...
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    Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable'

    A generic drug industry group and several companies have taken issue with recent US Food and Drug Administration (FDA) draft guidance on pre-submission facility correspondence (PFC) that spells out what companies need to do to obtain faster abbreviated new drug application (ANDA) reviews. In June, FDA released the draft guidance noting that it is "critical" for there to be a two-month lead time to determine whether facility inspections will be needed for the 8-mon...
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    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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    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...
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    China to Begin Priority Reviews of Medical Devices in January 2017

    China Food and Drug Administration (CFDA) announced Thursday that its priority review and approval procedure for medical devices will come into force as of 1 January 2017. The move is part of CFDA’s implementation of reforms to its approval systems for drugs and devices, and to meet the clinical demands of medical devices. According to the law firm Ropes & Gray , the new policy, first drafted in June, will allow applicants with a Class II device (limited to importe...
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    GDUFA II: FDA Looks to Speed Up Generic Drug Approval Process

    On 21 October, the US Food and Drug Administration (FDA) will meet to discuss plans for the second iteration of the Generic Drug User Fee Act (GDUFA II) under which FDA says it will begin offering eight-month and 10-month reviews of abbreviated new drug applications (ANDAs) between 2018 and 2022. The speed at which FDA reviews and approves ANDAs has been a hot topic lately, particularly as at least 315 generics have doubled in price since 2010 and many of those seein...
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    House E&C Committee Clears New Priority Review Voucher Program

    The House Energy & Commerce Committee late Wednesday pushed through a bill that will create a new priority review voucher (PRV) program for medical countermeasures that will not sunset. The new PRVs for medical countermeasures, if passed by the full House and Senate, would be the third PRV program in existence (in addition to the rare pediatric disease and neglected tropical disease PRV programs ) and the first to not sunset. Like the other two PRV programs, HR 3299...
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    FDA Lacks Reliable, Accessible Postmarket Data on Drugs, GAO Says

    The US Food and Drug Administration (FDA) does not have reliable, readily accessible data on safety issues and postmarket studies for drugs approved through expedited review pathways, the Government Accountability Office said in a report released Thursday. The report dug into FDA’s Center for Drug Evaluation and Research (CDER) data, which received about 1,000 requests for fast track designation and breakthrough therapy designation (the other two expedited programs for r...
  • FDA Oncology Team Provides Insight into Review Process, Advisory Committees, Oncology Development

    In an interview this weekend with Biocentury TV , four employees of the Office of Hematology and Oncology Products (OHOP) sat down to provide insight in to the office, tips for regulatory professionals and their respective takes on oncologic drug development with Biocentury TV 's Steve Usdin. Dr. Paul Kluetz, a clinical reviewer for OHOP rejected the notion that OHOP incentives are aligned against the approval of products, saying that "there is no incentive to appr...