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STAT+: Pharmalittle: We’re reading about FDA guidance on AI, meds releasing ‘forever chemicals,’ and more

STAT

That could include anything from modeling to cut down on animal-based toxicology studies to developing AI-based clinical trial endpoints to evaluating adverse events after the FDA approves a drug.    Most of the compounds came from commonly prescribed medications including antidepressants and statins.

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Opinion: Compounding pharmacies offer a fix for shortages of essential drugs

STAT

At the urging of the Alliance for Pharmacy Compounding, the trade association I lead, the Food and Drug Administration in April 2020 issued temporary guidance allowing traditional compounding pharmacies, within tight regulatory guardrails, to prepare 13 Covid drugs from pure ingredients to meet hospitals’ urgent need.

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STAT+: What to know about concerns raised about compounded versions of Novo Nordisk’s Wegovy

STAT

In late May, the Food and Drug Administration said it received a “few” adverse event reports concerning compounded versions of the injectable medicines, which both contain the same active ingredient, known as semaglutide.

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STAT+: Eli Lilly weight loss drug shortage underscores deeper issues with FDA oversight

STAT

A turbulent series of events surrounding the supply of Eli Lilly’s blockbuster weight loss treatment has raised concerns around how the Food and Drug Administration maintains its list of drug shortages and which sources it relies on, an issue that affects a growing number of Americans. Continue to STAT+ to read the full story…

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STAT+: A controversial new study examines traditional Chinese medicine’s potential cardiac benefits

STAT

A traditional Chinese medicine compound used for cardiac benefits might help reduce the incidence of major adverse cardiac and cerebrovascular events and even cardiac death rates, according to a new study published Tuesday in the Journal of the American Medical Association. Continue to STAT+ to read the full story…

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STAT+: Eli Lilly weight loss drug shortage underscores deeper issues with FDA oversight

STAT

A turbulent series of events surrounding the supply of Eli Lilly’s blockbuster weight loss treatment has raised concerns around how the Food and Drug Administration maintains its list of drug shortages and which sources it relies on, an issue that affects a growing number of Americans. Continue to STAT+ to read the full story…

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US FDA flags dosing risks from compounded versions of Novo’s weight-loss drug

Express Pharma

Food and Drug Administration recently warned patients and doctors about dosing errors associated with compounded versions of Novo Nordisk’s weight-loss and diabetes drugs. It urged healthcare providers and compounders to provide the appropriate syringe size and counsel patients on how to measure the dose,” informed the statement.