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Guide on Gene Therapy Observational Studies

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Long Term Follow-Up After Administration of Human Gene Ther...

FDA Warning on Nicotine Toothpicks

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FDA issues a Warning Letter to Smart Toothpicks (Tempe, AZ) after the agency determined that its dissolvable tobacco products, Pep...

Guide on Creutzfeldt-Jakob Disease Risk Reductions

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Federal Register notice: FDA makes available a draft guidance on recommendations to reduce the possible risk of transmission of Cr...

Olympus Enhanced Reprocessing Duodenoscope Cleared

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FDA clears an Olympus 510(k) for the TJF-Q190V duodenoscope with a sterile, disposable distal endcap for enhanced reprocessing.

Hahns 1st Address Targets Data Modernization as Priority

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In his first address to FDA employees, FDA commissioner Stephen Hahn says unleashing the power of data will be a key objective whi...

Medtronic Cybersecurity Patches for Cardiac Devices

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FDA says that Medtronic has released the first round of software updates to address some cybersecurity vulnerabilities identified ...

FDA Approves Peanut Allergy Drug

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FDA approves Aimmune Therapeutics Palforzia [peanut (Arachis hypogaea) allergen powder-dnfp] for treating peanut allergies.

FDA Seeks Bacitracin for Injection Market Withdrawal

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FDA requests that all bacitracin for injection manufacturers voluntarily withdraw their product from the market because the benefi...

FDA Approves Teva's Ajovy Autoinjector

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FDA approves a Teva Pharmaceuticals an autoinjector device for its Ajovy (fremanezumab-vfrm) injection for preventing migraine in ...

Aprea Therapeutics Breakthrough for Azacitidine

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FDA grants Aprea Therapeutics a breakthrough therapy designation for APR-246 in combination with azacitidine for treating myelodys...