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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 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 …
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 …
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, …
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 …
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 …
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 …
