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Panel to Discuss Flu Vaccine Strain Selection

[ Price : $8.95]

Federal Register notice: FDA announces a 10/6 Vaccines and Related Biological Products Advisory Committee meeting to discuss the v...

FDA Approves Bayer Mirena sNDA

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FDA approves a Bayer sNDA for its Mirena intrauterine system for extended use of up to eight years as a contraceptive.

Astellas Files NDA for Vasomotor Symptom Therapy

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FDA accepts for priority review an Astellas Pharma NDA for fezolinetant, a nonhormonal compound for treating moderate to severe va...

FDA Warning on Retractable Needles

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FDA warns about the potential for needle stick injuries from recently recalled Haiou Needle Retractable Safety 1 mL syringe with 2...

Fall Covid Boosters on Fast Track with Mouse Data

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FDA is permitting Covid-19 vaccine makers to submit mouse data to expedite authorization of their omicron-protecting vaccine boost...

Final Rule on OTC Hearing Aids

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

Respironics Ventilator MDRs Increase

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

Preceptis Device Cleared for Ear Tube Procedures

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

Gene Therapy OKd for Blood Disorder

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

FDA Cybersecurity 2022 Guidance Explained

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