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Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law Blog

The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. California Stem Cell Treatment Center, Inc., Stem Cell Clinic, LLC , 998 F.3d

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Discovery of MicroRNA Genetic Regulation Leads American Scientists to Win 2024 Nobel Prize

XTalks

The 2024 Nobel Prize in Physiology or Medicine has been awarded to American scientists Victor Ambros and Gary Ruvkun for their groundbreaking discovery of microRNA (or miRNA) and its role in post-transcriptional gene regulation. A gene contains instructions within our DNA.

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Opinion: The FDA is the right agency to regulate CBD products, but it needs help

STAT News

The dietary supplement industry has been begging for federal oversight of products containing cannabidiol (CBD), a non-psychoactive compound found in the cannabis plant that is being incorporated into a bewildering range of oils, tinctures, edibles, and other products. But the FDA turned down industry trade groups , and for good reason.

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MHRA publishes guidance on medicine regulation after Brexit

pharmaphorum

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If

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After Covis' Makena pull, EU regulator flags safety and efficacy problems with similar preterm birth drugs

Fierce Pharma

A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns. Following a controversy over Covis’ preterm birth drug Makena in the U.S.

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Common medications contain animal byproducts, study finds

Scienmag

No FDA regulations in place to alert patients when medication is derived from animals More physicians and pharmacists are advocating for patients to be made aware of animal byproducts contained in common medications, according to new research in the Journal of Osteopathic Medicine.

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CBD Research: A Dive into the Regulations of Cannabis Research

Advarra

Cannabis plants and derivatives containing no more than 0.3% Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act.