2023, Diagnosis, Manufacturing and Patient-Centered

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2023

Diagnosis

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Patient-Centered

Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Whether academic medical centers should be treated differently than other laboratories offering LDTs.

Provider

Provider Manufacturing IT Medical

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K. HHS forwards FDA’s analysis and recommendation to DEA.

Medical

Medical Physicals IT Healthcare Professional

Primary Care Digest

Proposed LDT Rule Raises Many Questions but Provides Few Answers

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

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