• Regulatory NewsRegulatory News

    FDA explains the ins and outs of real-time oncology review program in new guidance

    Cancer drugs under development that show substantial promise over existing therapies and have simple study designs, as well as easy to interpret endpoints, may qualify for a head-start review from the US Food and Drug Administration (FDA). While the drug will ultimately be reviewed under the same user fee time frame as other products, it may help speed up the review process for sponsors.   On 22 July, FDA published a draft guidance titled, Real-Time Oncology Review (...
  • ReconRecon

    Recon: Novartis' Leqvio nabs NICE nod; HebeCell makes a foray into CAR-NK space

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US When Will the Delta Surge End? ( NYT ) Why can’t America fix its Covid-19 testing problems? ( VOX ) Vaccination Rates Rose In August As COVID Cases Surged Due To The Delta Variant ( NPR ) First vaccination doses up 17 percent since Pfizer approval: analysis ( The Hill ) Companies eye financial penalties for unvaccinated workers ( The Hill ) America has waste...
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    Appeals court overturns FDA’s ban of electric shock device

    In a 2-1 decision, a federal court of appeals in Washington, DC struck down the US Food and Drug Administration’s (FDA) ban on electrical stimulation devices (ESDs) used at a single facility in Massachusetts to treat self-injurious behavior (SIB) or aggressive behavior (AB).   The US Court of Appeals for the DC Circuit, in siding with the plaintiffs, found that FDA’s ban on the devices for their particular use is not supported under statute and infringes on the practic...
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    Oncology research mid-pandemic: Challenges may bring durable innovation

    Though clinical research in general has been challenged during the COVID-19 pandemic, oncology trials “have several unique considerations due to disease severity, regimen complexity, and acute care requirements” that have caused even greater challenges, US Food and Drug Administration (FDA) officials wrote in a new viewpoint published in JAMA Oncology .   Data integrity issues and “pandemic-induced protocol deviations” are a concern for sponsors and FDA alike, and the...
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    FDA Launches Expanded Access Pilot ‘Project Facilitate’

    The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients.   “The FDA has been working diligently to improve the Expanded Access framework, including development of an updated and more streamlined application form, but despite recent improvements, we understand that for many patients or health care professionals, especially those not fami...
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    FDA's Woodcock, Marks and Pazdur Talk Sustainability and New Approaches

    Three of the US Food and Drug Administration's (FDA) top experts sat together on a panel at the third Biopharma Congress in Washington, D.C. on Tuesday, discussing everything from where the agency is headed in the next several years, how the costly clinical trial system is not sustainable and how they interview prospective FDA employees. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), reiterated a claim she made back in September ...
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    Advances in Sequencing Likely to Shift Paradigm in Cancer Drug Approvals, FDA Experts Say

    Experts within FDA's newly established Oncology Center of Excellence (OCE) discussed the office's role in the first site-agnostic cancer treatment approval and programs for further advancing oncology-related regulatory science and policy. And in the concluding section of the article, the OCE experts note that FDA, which has typically approved companion diagnostics under a "one drug, one diagnostic" paradigm, is "likely to" shift to a "many drugs, a panel of diagnos...
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    FDA’s Pazdur and Blumenthal: The March of Checkpoint Inhibitors Will Continue

    More approvals of new immune-checkpoint inhibitors, targeted and personalized therapies, as well as the use of real-world evidence are coming in the near future, Richard Pazdur, director of the Office of Hematology and Oncology at the US Food and Drug Administration (FDA) and associate director Gideon Blumenthal wrote in a comment published this week in Nature . Those expectations follow 2016 oncology approvals for FDA that included five new molecular entities and 17 ef...
  • Feature ArticlesFeature Articles

    CFDI's Global Drug Inspection Trend Study Offers Regulatory Updates and Opinions

    To help keep regulatory professionals up-to-date on current thinking by global regulatory agencies, the Chinese Center of Food and Drug Inspection (CFDI) released a new electronic journal covering hot topics and developments in international drug manufacturing inspections. This article summarizes the key points including regulatory thinking and opinions from global regulatory authorities and organizations; timely updates on regulations, guidance, regulatory measures and ...
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    Pazdur to Head New Oncology Center at FDA

    Vice President Joseph Biden on Wednesday named the US Food and Drug Administration's (FDA) top oncologist, Dr. Richard Pazdur, to head the newly formed Oncology Center of Excellence (OCE). The OCE is intended to accelerate the development of new oncology products, as part of Biden's $1 billion dollar cancer "Moonshot" initiative, by working with FDA's other centers for drugs, biologics and medical devices to promote a "cross-center" approach to reviewing oncology product...
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    GAO Offers Sharp Critique of FDA’s Lack of Measurable Regulatory Science Goals

    The Government Accountability Office (GAO) on Wednesday released two reports criticizing the Food and Drug Administration (FDA), one that says FDA lacks measurable goals to assess its progress in advancing regulatory science, and another that says FDA should better coordinate between its medical product centers. On the regulatory science front, GAO notes that FDA issued strategic planning documents in 2011 and 2013 to guide its regulatory science and identify priority...
  • RAPSRAPS' Latest

    Knowledge Center Provides RAPS Members With Free Content

    • 13 June 2016
    RAPS members now have a new and powerful tool to help them stay informed. The Member Knowledge Center , a new members-only content portal, provides a catalog of carefully curated free RAPS resources in one convenient place. The Knowledge Center gives members exclusive access to RAPS’ educational resources. “We wanted to find a way to help our members engage with RAPS’ high-quality products,” said Lindsay Currie, RAPS’ director of stakeholder engagement. “We plan to regu...