• Regulatory NewsRegulatory News

    EMA to Revise Herbal Medicines Guideline

    The European Medicines Agency (EMA) on Thursday opened for public comment a draft revision to its scientific guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicines. The revision, which comes 10 years after the first guideline was released, looks to update the current standards based on advances over the last 10 years, as well as because of newly established ...
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    FDA Offers New Draft Guidance on How to Co-Develop IVDs, Therapeutics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the need for such a treatment, is pushing the US Food and Drug Administration (FDA) to release new and more detailed draft guidance on how companies can co-develop a therapeutic alongside what the agency is calling an in vitro companion diagnostic device, or IVD companion diagnostic.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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    Two Draft FDA Guidelines on NGS Set Foundation for Precision Medicine Initiative

    New next generation sequencing (NGS) technologies that can examine millions of DNA variants at a time and help inform treatment decisions are at the heart of two new draft guidance documents released Wednesday evening by the US Food and Drug Administration (FDA) as part of President Barack Obama’s Precision Medicine Initiative. FDA says the guidance offers a streamlined approach to the oversight of diagnostics that detect medically important differences in a person’s gen...
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    Regulating Precision Medicine: Capacity vs. Overreach

    As the boundaries between the clinic, the research lab and industry continue to shift, researchers are calling on the US Food and Drug Administration and other similar regulators worldwide to tread carefully in how they effectively facilitate the practice of precision medicine. In an article published online this week in the Journal of Law and the Biosciences , titled “Precision medicine: drowning in a regulatory soup?” a group of mostly Australian researchers note that...
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    Precision Medicine: Technology, Regulations and Challenges

    • 11 March 2016
    This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare. As the field of Precision Medicine (PM) continues to escalate on the trajectory from hypothesis-driven conception to customary clinical best practice, there are facets impacting not only commercial product developers, but also select general public subgroups in dire need of ind...
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    Precision Medicine: Technology, Regulations and Challenges

    This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare. As the field of Precision Medicine (PM) continues to escalate on the trajectory from hypothesis-driven conception to customary clinical best practice, there are facets impacting not only commercial product developers, but also select general public subgroups in dire need of ind...
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    Asia Regulatory Roundup: CFDA Consults on Good Supply Practices, Traceability (23 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Reviews Good Supply Practices After Suspending Ali Health-run Platform The China Food and Drug Administration (CFDA) has begun a consultation on good supply practices and traceability after suspending the use of a drug monitoring system run by Alibaba-subsidiary Ali Health. In revising its traceability document, CFDA has removed references specific to the electro...
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    FDA Regulation and Personalized Medicine

    This article discusses examples of personalized medicine in industry as well as examples of FDA regulatory activities with respect to personalized medicine. "Personalized medicine" or what also has been referred to as "precision medicine"has a variety of definitions, ranging from broad to narrow. The European Union and the President's Council of Advisors on Science and Technology provide broad definitions for personalized medicine, while the National Academy of Science...
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    Senate Bill Seeks to Create Standards Body for Regenerative Medicine

    Sen. Tammy Baldwin (D-WI) introduced a bill on Tuesday to promote the development of regulatory science and standards for regenerative medicine and advanced therapies. The bill, known as the Advancing Standards in Regenerative Medicine Act , would require the US Food and Drug Administration (FDA) to oversee the creation of a "Standards Coordinating Body" for regenerative medicine. Regenerative medicine and advanced therapies belong to a growing field of medicine that i...
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    Tufts Outlines Regulatory Initiatives to Spur Innovation in 2016

    Further harmonization among major regulatory agencies globally will look to focus on pediatric drug studies in 2016, according to a new report from the Tufts Center for the Study of Drug Development. The report released this week outlines not only what the drug development industry should expect for 2016, but also how regulators will play a major role in keeping drugs safe and in some cases extending marketing exclusivity periods for certain classes of drugs deemed crit...
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    precisionFDA Launches to Help With NGS Assay Validation, Data Sharing

    In the spirit of sharing, the US Food and Drug Administration (FDA) on Tuesday launched precisionFDA, a new online, cloud-based platform where genomics experts from industry, academia, government and elsewhere can come together and securely share data on next-generation sequencing (NGS). The beta-launch of the site opens the door for accessing and sharing datasets, analysis pipelines, bioinformatics tools and other approaches that also could advance regulatory science. ...
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    FDA Officials Review Algorithms Used for NGS Analysis

    A group of scientists from the US Food and Drug Administration's (FDA) Division of Bioinformatics and Biostatistics have reviewed the algorithms used to align the data generated by next-generation sequencing (NGS) tests to reference genomes. NGS tests hold great promise for precision medicine due to their ability to quickly sequence the human genome and identify thousands of genetic variants. By identifying genetic variants that are associated with different diseases, r...