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    • Join Top Genomics and Regulatory Experts to Analyze the Law Governing Genomics Research, Data, and Clinical CareFebruary 25th, 2020

      Genetics and genomics are becoming crucial to clinical care. As the “precision medicine” revolution spreads, cancer treatment, rare disease diagnosis, and cardiac care increasingly utilize genomics. Unfortunately, law and policy lag behind science, and the law governing genomics remains unclear – which means the time …

    • Does Your Unapproved Device, Drug or Biologic Qualify for an Emergency Use Authorization (EUA)?February 14th, 2020

      The FDA is taking very seriously the threat of the coronavirus from China (2019‑nCoV).  Makers of medical devices, drugs and biologics should consider whether their products can contribute to countering this threat. In late January, FDA announced its strategy to advance development of medical countermeasures to …

    • Richard Lewis Joins HP&M as Senior Regulatory Device & Biologics ExpertFebruary 12th, 2020

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Richard Lewis has become its newest Senior Regulatory Device & Biologics Expert.   Coming to us after more than 4 years at FDA, Richard worked in the Center for Biologics Evaluation and Research (CBER) and …

    • FDA Law Alert – February 2020February 10th, 2020

      Hyman, Phelps & McNamara, P.C. is pleased to publish the first FDA Law Alert of the new year. This is the fourth installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to …

    • FDA Says That Theranos Discovery Strain Is Causing Other FDA Enforcement Efforts to Take a BackseatJanuary 16th, 2020

      About eighteen months ago, the government accused former Theranos founder Elizabeth Holmes and former Theranos president Ramesh “Sunny” Balwani of wire fraud and conspiracy, a scheme that fooled investors into providing more than $700 million to the then-promising blood-testing startup. In the latest development in US …

    • The Vanishing PMA Device Advisory Panel MeetingJanuary 15th, 2020

      Under the Federal Food, Drug, and Cosmetic Act, FDA is authorized to hold advisory panel meetings for premarket approval applications (PMAs).  While FDA originally had to hold a panel meeting for all PMAs pursuant to the Medical Device Amendments of 1976, Congress liberalized the law …

    • HP&M Files Citizen Petition Challenging FDA’s Restrictions on Pharmacogenomic DataJanuary 14th, 2020

      Over the years, we have blogged many times on FDA’s approach towards laboratory-developed tests (LDTs) (see, e.g., prior posts here, here, here, here, and here).  On October 31, 2018, FDA issued a Safety Communication relating to one particular type of LDT: pharmacogenomic (PGx) assays.  On …

    • Court Decides FDA Can’t Regulate Device as DrugDecember 9th, 2019

      The distinction between a drug and a device is a critical one: drugs and devices are subject to different regulatory schemes, with the drug pathway being significantly more onerous and expensive.  User fees alone for a generic drug total $300,000 for the first year compared …

    • The Theranos Saga Continues: Court Requires Government to Produce DocumentsNovember 18th, 2019

      On November 5, 2019, the U.S. District Court for the Northern District of California ruled in favor of Theranos founder Elizabeth Holmes and former Theranos president Sunny Balwani, in a battle over access to government documents.  While this represents a small victory for these defendants, …

    • FDA Finalizes Guidance on Process to Request Review of CFG DenialNovember 14th, 2019

      FDA is issuing final guidance on how device firms may request review of a decision to withhold issuance of a Certificate to Foreign Government (CFG).  What is a CFG?  In many cases, foreign governments will seek official assurance that products exported to their countries are …

    • FDA Law Alert – November 2019November 6th, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to publish the third installment of the FDA Law Alert, a quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and …

    • Regulation of Laboratory Developed Tests by FDA: Time for the Agency to Cease and Desist Until Congress Enacts LegislationOctober 21st, 2019

      A warning letter issued earlier this year by the Food and Drug Administration (FDA) to Inova Genomics (Inova) prompts some reflections on where things stand now with the regulation of laboratory developed tests (LDTs) under the Federal Food, Drug, and Cosmetic Act (FDCA).  An LDT, …

    • Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures ActOctober 4th, 2019

      Nearly three years after Section 3060(a) of the 21st Century Cures Act amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by removing certain software functions from the device definition in section 201(h) of the FD&C Act, FDA has released Changes to …

    • FDA Issues a Second Draft Guidance for Clinical Decision Support SoftwareOctober 1st, 2019

      On September 27, 2019 FDA issued several updates to advance their digital health policies.  One of these updates was a new draft guidance, Clinical Decision Support Software (“Guidance”).  This draft guidance replaces the 2017 draft guidance, Clinical and Patient Decision Support Software (“Prior Draft”), which …

    • CDRH Issues Draft Guidance on Safer Technologies ProgramSeptember 30th, 2019

      FDA formally announced the Safer Technologies Program (STeP) in a December 2018 press release from then-FDA Commissioner Scott Gottlieb, M.D., and Director of CDRH Jeff Shuren, M.D.  Details on the program were limited other than to say that the program would be designed to complement …