• Regulatory NewsRegulatory News

    GDUFA Science Priorities for 2017: Postmarket Evaluation and Complex Generics

    In the final year of the first Generic Drug User Fee Act (GDUFA I), FDA’s Office of Generic Drugs (OGD) is planning to prioritize the post-market evaluation of generics, work on the equivalence of complex generics and locally acting products, as well as new standards and computational and analytical tools. The release of OGD’s regulatory science priorities on Thursday comes as 2016 saw a banner year for generic approvals, with 651 approvals (or 835 if tentative approv...
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    A Look Into the Future: FDA Wants to Know What’s Coming for Scientific Advances

    New advances in gene editing, precision medicine and synthetic biology are all likely to have a major impact on how the US Food and Drug Administration (FDA) shapes its regulations in the near- and long-term. Now, FDA is formally asking interested parties to offer some fresh perspectives on these and other emerging technologies and cross-cutting scientific advances that could be of importance to FDA, with a focus on areas that may impact FDA in five to 10 years. “FDA's ...
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    RAPS' New Book Offers 36 Articles on Eclectic Science Topics for Curious Readers

    RAPS has just published a new book that offers curious readers a collection of 36 brief, interesting articles on a range of science and regulatory topics, some published for the first time. The new book, Eclectic Science and Regulatory Compliance: Stories for the Curious , by Max Sherman, is a follow-up to his popular 2012 book From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories . Topics Sherman covers in Eclectic Science include mindful...
  • Feature ArticlesFeature Articles

    The Innovation Imperative for Biopharmaceutical Regulatory Science: Three Emerging Trends

    This article discusses how manufacturers' regulatory affairs functions could improve their conduct of regulatory science through adaptive pathways, joint scientific and health technology assessment advice and patient-centricity. The Innovation Imperative for Regulatory Science The US Food and Drug Administration (FDA) defines regulatory science as "the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance o...
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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...
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    CDRH Unveils Top Regulatory Science Priorities for 2016

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will look to better leverage big data and advance the use of patient-reported outcomes in regulatory decision making, according to a top 10 list of regulatory science priorities released on Tuesday. The release of the list coincides with the overarching goal of CDRH regulatory science, which is to help develop and apply tools, standards and methodologies to study the safety, eff...
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    FDA Science Board Calls on Agency to Find New Ways to Stimulate Biomedical Innovation

    The US Food and Drug Administration (FDA) has made “significant strides” in strengthening its scientific capabilities, though there is still some concern about the agency’s ability to support and stimulate biomedical innovation, according to a new report from a subcommittee of FDA’s Science Board. Background Six years after a 2007 report from the Science Board -- which, among other findings, called attention to FDA’s “weak scientific base and inadequate scientific wor...
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    Eight Years on, FDA Celebrates its Scientific Advancement

    Last week, the US Food and Drug Administration announced the release of a new report, FDA Science Moving Forward, showcasing the agency's scientific advancements since 2007. Major Changes Since 2007                                                                                  In 2007, FDA's Science Board released a report, FDA Science and Mission at Risk, which predicted that "rapid developments" in emerging scientific disciplines such as genomics, personalized ...
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    Japan Edges out FDA for Fastest Approvals

    In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs). New Drug Approvals in ICH Countries A new report by the Centre for Innovation in Regulatory Science (CIRS), New Drug Approvals in ICH Countries 2005-2014 , examines NAS approvals in the US, EU and Japan. The report finds that FD...
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    FDA Making Changes to its Drug Advertising Review Process

    A new guidance document finalized by the US Food and Drug Administration (FDA) proposes to make it easier for pharmaceutical marketing professionals to submit their advertisements and promotional materials for review by regulators. Background At present, all pharmaceutical advertisements aired or distributed by companies must be submitted to FDA's Office of Prescription Drug Promotion (OPDP)—formerly known as the Division of Drug Marketing, Advertising and Communication...
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    FDA Plans to Fund Research on Generic Drug Efficacy, Medical Countermeasures and More

    The US Food and Drug Administration (FDA) hopes to obtain private sector help to improve nine areas of regulatory science, including the evaluation of generic drug effectiveness and expedited ways to assess drugs to treat the world's most dangerous diseases, the agency said this week in a new Broad Agency Announcement (BAA) . Background The posting of the BAA is an annual tradition for FDA. The announcement outlines the research and development topics the agency hopes ...
  • Regulatory NewsRegulatory News

    FDA Looking for a Leader for its New Device Testing Division

    The US Food and Drug Administration (FDA) is on the hunt for a new leader for its device center's newly formed Division of Biology, Chemistry and Materials Science (DBCMS). The new division, housed within the Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Laboratories (OSEL), is primarily concerned with how medical devices physically interact with patients. For example, its staff will be assessing devices for biocompatibility, biolo...