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  • Regulatory NewsRegulatory News

    Digital health tech in clinical investigations: FDA issues draft guidance

    The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish to use digital tech to aid in remote clinical data acquisition.   Digital health technologies (DHTs) stand to benefit clinical investigations in a multitude of ways, but regulatory considerations have to be weighed as the technologies are employed, noted the agency in setting out the background for the draft guidance, issued in l...
  • Feature ArticlesFeature Articles

    The regulatory landscape of advanced therapies in Asia-Pacific

    The Asia-Pacific region, which inlcudes Australia, China, Hong Kong, Japan, Malaysia, Singapore, and South Korea, has a significant number of clinical trials in advanced therapies, with China ranking second globally. Manufacturers in other countries in the region, such as Japan, Australia, South Korea, and Singapore, have submitted marketing authorizations applications for advanced therapies and received approvals. Regulators recognize this emerging trend in dynamic resear...
  • Regulatory NewsRegulatory News

    FDA recognizes Memorial Sloan Kettering tumor variant database

    The first somatic human variant database has been recognized by the US Food and Drug Administration for inclusion in its Public Human Genetic Variant Database listing. The move opens the door for developers of tumor profiling tests to use the database to support clinical validity claims in regulatory submissions.   A portion of Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OnkoKB) received the recognition under FDA’s database recognition program. ...
  • Regulatory NewsRegulatory News

    Digital health collaborative aims to build in equity and inclusion

    A newly minted collaborative of industry, government, and patient groups is seeking to develop a set of best practices that will help make digital health measurement technologies work for all users, regardless of gender, race, ethnicity, and other factors.   The Digital Health Measurement Collaborative Community ( DATAcc ), launched in May 2021, is hosted by the nonprofit Digital Medicine Society (DiMe) and brings together more than 30 organizations, including the US F...
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    FDA guidance says sponsors should provide 'convincing' proof of concept data to support INDs for individualized medicine

    Recent draft guidance from the US Food and Drug Administration addresses the non-clinical safety data to support investigational new drug applications (INDs) for individualized antisense oligonucleotide (ASO) products, a type of personalized medicine.   The guidance, issued on 26 April, addresses INDs for ASOs that treat a severely debilitating or life-threatening disease caused by a unique genetic variant. Such diseases may be amenable to RNA-directed treatment.   ...
  • Regulatory NewsRegulatory News

    Time's up for questionable cell and tissue products, says Marks

    Purveyors of unapproved cellular-derived treatments are about to find out what happens when the US Food and Drug Administration ends its period of enforcement discretion for these regenerative medicine products.   A three-year clock for enforcement discretion began when FDA announced its regenerative medicine policy framework in November 2017; the COVID-19 pandemic prompted a 6-month extension, announced the agency last summer. Time is now up, and no more extensions ...
  • FDA launches digital health center of excellence

    A new digital health Center of Excellence within the US Food and Drug Administration (FDA) aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.   The DHCoE’s website details services offered, including examples of CDRH-specific, FDA-wide and external efforts to “translate digital advances into tools that benefit consumers.” The Center is housed within FDA’s Center for Devices and Radiological Health (...
  • Feature ArticlesFeature Articles

    Update on RMAT designations

    This article discusses the scope and purpose of the special designation for regenerative medicine advanced therapies (RMAT) created by the passage of the 21st Century Cures Act. The authors explain the benefits expected to be realized with RMAT and provide a tally of products receiving the special designation to date and a current count, by year, of products for which RMAT designation has been requested.   Introduction Section 3033 of the 21st Century Cures Act, titl...
  • Feature ArticlesFeature Articles

    Bespoke therapies – opportunities, challenges, and hope

    This article discusses the advent of bespoke therapies, defined as the tailoring of medical treatment to the individual characteristics or symptoms and responses of a patient during all stages of care and as a new frontier beyond personalized medicine. The author covers the revolutionary genetic tools implementing such therapies and the clinical and nonclinical safety perspectives for bespoke therapies. The author concludes that with bespoke therapies we are entering a new...
  • Regulatory NewsRegulatory News

    FDA Explains What Mobile Apps Are No Longer Devices

    A section of the 21st Century Cures Act (Cures Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and removed certain software functions from the definition of a medical device. In addition to drafting new guidance on clinical decision support software, the US Food and Drug Administration (FDA) on Thursday released final guidance explaining what digital health products are no longer devices and are no longer subject to FDA regulations. Examples of such...
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    Regulating Digital Health: Novartis CEO Seeks Further Modernization

    Novartis CEO Vas Narasimhan told attendees of PhRMA’s Innovation Day on Thursday that as biopharmaceutical companies embrace digital technologies to speed the discovery and development of new medicines, regulators will have to adapt more quickly. “FDA has been, more than any other regulator in the world, interested in working with these technologies,” Narasimhan said. But he also opined that when the “rubber hits the road” and companies begin filing applications with th...
  • Regulatory NewsRegulatory News

    Digital Health: ‘Connecting the Dots’ Across FDA Centers

    The US Food and Drug Administration’s (FDA) creation of a Digital Health Center of Excellence is in the works, although details offered Wednesday did not shed much light on when it’s coming or its envisioned role.   There are “lots of details to be ironed out,” said Bakul Patel, director for digital health at FDA’s Center for Devices and Radiological Health (CDRH), during a session on Wednesday at the AAMI/BSI/FDA International Conference on Medical Device Standards an...