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Biologics

Fall Covid Boosters on Fast Track with Mouse Data

FDA is permitting Covid-19 vaccine makers to submit mouse data to expedite authorization of their omicron-protecting vaccine boosters, a move some see...

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Federal Register

Final Rule on OTC Hearing Aids

Federal Register final rule: FDA establishes a regulatory category for over-the-counter hearing aids and making related amendments to update the regul...

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Medical Devices

Respironics Ventilator MDRs Increase

FDA says it has received 168 reports of deaths in more than 69,000 medical device reports associated with PE-PUR foam degradation in Philips Respironi...

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Medical Devices

Preceptis Device Cleared for Ear Tube Procedures

FDA clears a Preceptis Medical 510(k) for expanded indications for its Hummingbird Tympanostomy Tube System for office-based pediatric ear tube proced...

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Biologics

Gene Therapy OKd for Blood Disorder

FDA approves the first cell-based gene therapy for treating adult and pediatric patients with beta-thalassemia who require regular red blood cell tran...

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Medical Devices

FDA Cybersecurity 2022 Guidance Explained

Attorney Brynn Stanley outlines provisions in a 2022 FDA draft cybersecurity guidance and how they differ from the 2018 draft it replaced.

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Biologics

Brainstorm to File BLA for Lou Gehrigs Disease

Brainstorm Cell Therapeutics says it will submit a BLA for it NurOwn stem cell therapy for treating amyotrophic lateral sclerosis.

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FDA General

Califf on New Ecosystem to Fight Disinformation

FDA commissioner Robert Califf tells FDA Webview his agency is joining with other entities, especially universities, to form a new ecosystem to find s...

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Federal Register

Guide on OTC Hearing Aids

Federal Register notice: FDA makes available a final guidance entitled Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplificatio...

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Human Drugs

Circulating Tumor DNA Seen Useful in Cancer Treatment

Cancer researchers say circulating tumor DNA may be an important tool in clinical development and an early indicator of treatment benefit.