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Senators Want More Covid Vaccine Data

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Sens. Collins and Burr ask FDA and CDC to make more data available on Covid vaccine efficacy and breakthrough infections.

FY 2021 Enforcement Stats Decimated by Covid

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FDA updates its fiscal year (FY) 2021 FDA enforcement and compliance data, which show just how badly Covid-19 has decimated the ag...

Cook Medical Recalls Transseptal Needle

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FDA says Cook Medical has recalled all unexpired lots of its transseptal needle and transseptal needle with catheter due to the pr...

FDA Allows More, Mixed Booster Vaccines

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FDA authorizes Covid-19 vaccine booster doses for certain Moderna and Johnson & Johnson vaccinated individuals; it also authorizes...

House Passes Drug Continuous Manufacturing Bill

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The House passes Rep. Pallones bipartisan National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing l...

Stealth Bio NDA Gets Refuse-to-File Letter

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FDA sends Stealth BioTherapeutics a refuse to file letter on its NDA for elamipretide, a mitochondria-targeted therapy for treatin...

QS Problems at Magnolia Medical Technologies

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FDA warns Magnolia Medical Technologies about Quality System regulation violations in its work as a specification developer for a ...

Updated Guide on Hearing Aid Devices

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Federal Register notice: FDA makes available a draft guidance entitled Regulatory Requirements for Hearing Aid Devices and Persona...

OTC Hearing Aids Proposed Rule

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Federal Register proposed rule: FDA proposes to establish a regulatory category for over-the-counter hearing aids and to make rela...

Court OKs FDA Injunction Against Grandmas Herbs

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The Utah federal court approves a permanent injunction sought by FDA preventing Grandmas Herbs and its owners from marketing dieta...