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    FDA Offers Two New Draft Guidances on Developing Targeted Therapies

    The US Food and Drug Administration (FDA) on Friday published two new draft guidance documents that seek to support the development of treatments that address underlying genetic mutations that often cause or contribute to diseases, and another discussing how to determine if an in vitro diagnostic (IVD) device used in a study must undergo its own FDA review, distinct from a drug study. "New drugs are being developed based solely on their ability to target these und...
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    FDA Announces Streamlined Review Pathway for DTC Genetic Tests

    The US Food and Drug Administration (FDA) on Monday detailed its plans to make it easier for companies developing direct-to-consumer (DTC) genetic health risk (GHR) tests to get those tests on the market. To do so, FDA is proposing a model similar to a pilot for digital health products, by which companies can be pre-certified to market low-risk software-based devices following an assessment of their systems for software design, validation and maintenance. Similarly, F...
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    FDA: Lead Test Company May Have Violated Federal Law

    The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems. FDA cited the issues in a 10-page inspection report stemming from a month-and-a-half long inspection of Magellan's North Billerica, MA facility from 10 May to 29 June 2017. A week into that inspection, FDA warned the public that all four of Magel...
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    FDA Approves First DTC Tests Evaluating Genetic Risk Information

    The US Food and Drug Administration (FDA) on Thursday authorized the first direct-to-consumer (DTC) genetic health risk tests for 10 diseases and conditions. The authorization for the genetic testing company 23andMe means individuals for the first time will be able to use these tests to understand their genetic predispositions for certain diseases and conditions without first seeing a doctor. “Consumers can now have direct access to certain genetic risk information,”...
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    EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research

    The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating that, when alternatives do not exist, the appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for pharmaceutical safety assessments. The opinion is part of a process to reevaluate the same conclusion from 2009 that “recognised that animals s...
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    Small Biopharma Face Distinct Challenges: FDA Official and Sanofi Genzyme SVP Argue

    Small biopharmaceutical companies, often known as the drivers of innovation, face a number of unique challenges in bringing new treatments, particularly for rare diseases, to market, Richard Moscicki, deputy director for science operations at the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, and P.K. Tandon, senior vice president of Sanofi Genzyme, wrote. In an article published Tuesday in the New England Journal of Medicine , the a...
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    FDA Revises Guidance on Safety Testing of Drug Metabolites

    The US Food and Drug Administration (FDA) on Tuesday released revised guidance on recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The revisions mean the new guidance supersedes guidance from February 2008. The guidance has been revised to be in alignment with ICH guidance, known as M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authori...
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    FDA Finalizes Guidance on Donor Screening to Reduce Hepatitis B Transmission

    The US Food and Drug Administration (FDA) on Wednesday finalized its guidance on reducing the risk of hepatitis B virus (HBV) transmission via human cells, tissues and cellular and tissue-based products (HCT/Ps) by screening donors with nucleic acid tests (NAT). Specifically, FDA says that HCT/P establishments should add nucleic acid tests for HBV to their testing arsenal as the new tests offer significant improvements in how early the virus can be detected. "FDA-licens...
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    FDA Offers New Draft Guidance on How to Co-Develop IVDs, Therapeutics

    The age of precision medicine, with treatments targeted to specific patients based on a companion test identifying the need for such a treatment, is pushing the US Food and Drug Administration (FDA) to release new and more detailed draft guidance on how companies can co-develop a therapeutic alongside what the agency is calling an in vitro companion diagnostic device, or IVD companion diagnostic. The draft released Thursday, entitled "Principles for Codevelopment of an...
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    Rodent Carcinogenicity Testing: Changes to ICH Guidance Proposed

    The European Medicines Agency (EMA) is considering changes to International Council for Harmonisation (ICH) guidance on rodent carcinogenicity testing to improve the evaluations, reduce use of animals and drug development resources and reduce timelines to market authorization in some cases without compromising patient safety. The goal of the potential changes to the S1 guidance, according to EMA, is to introduce a better way to address the risk of human carcinogenicity o...
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    Congressional Hearings Focus on Compassionate Use, FDA Issues

    Aside from Thursday’s summit on President Barack Obama’s Precision Medicine Initiative (which can be viewed in its entirety  here ), the Senate and House held two other hearings focused on the inner workings of the US Food and Drug Administration (FDA). At the Senate Homeland Security and Government Affairs Committee hearing, senators discussed FDA’s compassionate use program with the Goldwater Institute’s Dary Olsen, who’s been behind all of the Right-to-Try state legi...
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    FDA Raises Questions Over DTC Genetic Tests Offered at Rite Aid

    The US Food and Drug Administration (FDA) called out another direct-to-consumer (DTC) genetic testing company on Monday over an unapproved test, this time going after one recently made available at the drugstore chain Rite Aid. According to the letter from FDA, the swab tests from Tennessee-based Harmonyx, a College of American Pathologists-accredited and Clinical Laboratory Improvement Act-certified genetic testing laboratory, are meant to help patients determine if the...