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Cook Medical Recalls Transseptal Needle

[ Price : $8.95]

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

[ Price : $8.95]

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

House Passes Drug Continuous Manufacturing Bill

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Regulatory Requirements for Hearing Aid Devices and Persona...

OTC Hearing Aids Proposed Rule

[ Price : $8.95]

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

[ Price : $8.95]

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

CGMP Violations at Sircle Laboratories

[ Price : $8.95]

FDA warns Sircle Laboratories about CGMP violations in its production of finished drugs.

Akero Gains Fast Track for NASH Drug

[ Price : $8.95]

FDA grants Akero Therapeutics a fast track designation for efruxifermin and its use in treating non-alcoholic steatohepatitis (NAS...