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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

FDA Law

1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023, sesame. In addition to providing additional examples of tree nuts, the draft guidance states that FDA considers the following categories of fish to be major food allergens under Section 201(qq): Jawless fish (e.g.,

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Is ASCA worth it? FDA’s Accreditation Scheme for Conformity Assessment

FDA Law

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted. The MDUFA V reauthorization converts the ASCA Pilot to a permanent program.

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Direct-to-consumer advertising distorts prescription drugs’ benefits and costs

Common Sense Family Doctor

He argued that "the pharmaceutical industry should concentrate its efforts on educating physicians about its new products, not coercing patients to put pressure on physicians to make decisions that may not be necessary, beneficial or cost-effective." Who could blame a patient for believing the drug doesn’t cost much. But it is not free.

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Animals Need Drugs Too, But Not Without CVM Approval

FDA Law

Responsible for “Protecting Human and Animal Health,” CVM makes sure that the drugs, devices, and food we provide for our pets are safe and effective. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). And CVM certainly exercises that authority.

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Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. And they drive.

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Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

FDA Law

Senator Durbins letter references a January 2023 study from the Journal of the American Medical Association, which found that more than two-thirds of drugs advertised on television were considered to have low therapeutic value. Its unclear whether there are truly regulatory gaps that require new legislation.

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COVID Updates: A Podcast with Peter Chin-Hong and Lona Mody

GeriPal

Alex 00:23 And we’re delighted to welcome Peter Chin-Hong, who is an infectious disease physician and medical educator, professor at UCSF and associate dean for regional campuses. And when you look at the numbers, actually last year in 2023, even though we’re in a recovery phase, there were more than 75,000 deaths.