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Biotech, Food, and Drug Legal News
Hourly and around the clock, the National Law Review's editors screen and classify breaking environmental law news and analysis authored by recognized legal professionals and our own journalists.
In-house attorneys looking for a better way to organize, vet, and easily retrieve legal news created the National Law Review online edition.
There is no log-in to access the database and new articles are added hourly.
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FDA Issues Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
On May 6, 2024, the U.S. Food and Drug Administration published its anticipated final rule concerning oversight of laboratory-developed tests (LDTs). The final rule (i) affirms the FDA’s position that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FDCA), including when the manufacturer of the IVD is a laboratory; (ii) sets out FDA’s enforcement discretion phaseout policy for LDTs in stages; (iii) applies “targeted” enforcement discretion for certain categories of LDTs; and (iv) reiterates that certain other categories of LDTs, which receive either full enforcement discretion or no enforcement discretion at all, are not subject to the phaseout policy.
More on Laboratory-Developed Tests Rule Here >
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EPA, USDA, and FDA to Clarify Overlapping Biotechnology Regulatory Frameworks
On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and U.S. Food and Drug Administration (FDA) released a joint plan to identify areas of ambiguity, gaps, or uncertainty in their coordinated regulation of biotechnology products. Consistent with a directive issued by President Biden in September 2022, the agencies’ plan identifies specific issues that each has either recently addressed or will work to address to promote such products’ safe use.
More on Biotech Regulatory Frameworks Here >
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