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NeuroOne Medical Brain Electrodes Cleared

[ Price : $8.95]

FDA clears a NeuroOne Medical Technologies 510(k) for its Evo sEEG Electrode technology for temporary (less than 24 hours) use for...

Skinny Label Effectively Dead: Attorney

[ Price : $8.95]

Attorney Sara Koblitz says the generic drug industry has been upended by a Federal Circuit Court of Appeals ruling that Teva induc...

10 Observations in Toyobo FDA-483

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FDA releases the FDA-483 with 10 observations from an inspection at Japans Toyobo Co.

Panel to Weigh Future of Multiple Myeloma Therapy

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Federal Register notice: A 10/28 advisory committee discusses whether an accelerated approval for an Oncopeptides NDA for Pepaxto ...

HHS Restores its Delegation of Authority to FDA

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HHS restores FDAs authority to issues regulations without HHS authority, which was removed late in the Trump Administration.

FDA Accepts sNDA for Adult ADHD Drug

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FDA accepts for review a Supernus Pharmaceuticals supplemental NDA for Qelbree (viloxazine extended-release capsules) for treating...

MoleKule 510(k) Cleared for Air Purifier

[ Price : $8.95]

FDA clears a Molekule 510(k) for its existing air purifier, Air Pro, classifying it as a Class 2 medical device for medical use fo...

Mammography QA Panel Renewed for 2 Years

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Federal Register notice: FDA renews its National Mammography Quality Assurance Advisory Committee for an additional two years beyo...

Limited, Not Full-scale Booster Shots Mulled

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FDA cautions that it may only be able to give the green light for booster shots later this month to those vaccinated with the Pfiz...

Milestone Reached on Competitive Generic Therapies

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CDER Office of Generic Drugs reaches the milestone of approving more than 100 generic drug applications with a Competitive Generic...