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FDA Debars Ursula Wing

[ Price : $8.95]

Federal Register notice: FDA issues an order to debar Ursula Wing for a period of five years from importing or offering to import ...

OMB Approves 7 Information Collections

[ Price : $8.95]

Federal Register notice: FDA publishes a list of seven information collections that have been approved by OMB.

Whalen Debarred for 10 Years

[ Price : $8.95]

Federal Register notice: FDA issues an order to debar for 10 years Thomas J. Whalen from importing or offering for import any drug...

FDA Dismisses Concerns About Whether Approval Bar Raised

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CDERs Office of New Drugs says approval standards are unchanged, reacting to concerns about a raft of negative drug review decisio...

Medtronic Harmony Transcatheter Pulmonary Valve OKd

[ Price : $8.95]

FDA approves a Medtronic PMA for its Harmony Transcatheter Pulmonary Valve, the first minimally invasive therapy to treat patients...

At-Home Tests to Advance Due to Covid Experience: FDA

[ Price : $8.95]

CDRH officials reflecting on Covid-19 experience say at-home diagnostics will accelerate technological advances that benefit routi...

Panel Shoots Down Pfizer Arthritis Drug REMS

[ Price : $8.95]

An FDA advisory committee votes 19 to 1 that a Pfizer-proposed Risk Evaluation and Mitigation Strategy in its BLA for osteoarthrit...

Consider Benzedrex Design Changes: FDA

[ Price : $8.95]

FDA asks for changes to Benzedrex OTC decongestant inhalers to reduce the likelihood of abuse and misuse.

Alembic Pharmaceuticals Recalls 1 Lot of Telmisartan Tablets

[ Price : $8.95]

Alembic Pharmaceuticals recalls one lot of telmisartan tablets, USP, 20 mg, packaged in 30-count bottles due to a mislabeling conc...

AstraZeneca Covid Vaccine Efficacy Revised to 76%

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AstraZeneca revises its Covid-19 clinical trial vaccine efficacy rate from 79% to 76% under a primary analysis after the studys da...