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Glass Stoppers and Vials Guidance

[ Price : $8.95]

FDA publishes a guidance with recommendations for the reporting category and the content of post-approval changes for sterile drug...

OPDP to Study Multiple Indications in TV Ads

[ Price : $8.95]

The Office of Prescription Drug Promotion will study how multiple indications in consumer TV ads affect consumers recall and under...

Permanent Injunction Against Dietary Supplement Company

[ Price : $8.95]

A New York federal judge enters a permanent injunction against dietary supplement manufacturer Confidence USA and two of its execu...

Dupixent sBLA for Pediatric Asthma

[ Price : $8.95]

FDA accepts for review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on treatment for...

FDA Hit on Slow At-Home Covid Test Approval

[ Price : $8.95]

Taxpayers Protection Alliance senior fellow Ross Marchand says FDA needs to overcome its aversion to approving rapid home-based Co...

Former Insys Vice President Debarred

[ Price : $8.95]

Federal Register notice: FDA issues an order to permanently debarring former Insys vice president Michael Gurry from providing ser...

Physician Debarred Over Role at Internet Pharmacy

[ Price : $8.95]

Federal Register notice: FDA issues an order permanently debarring Lawrence B. Ryan from providing services in any capacity to a p...

EnMed Marketing Unapproved Covid Sample Kit: FDA

[ Price : $8.95]

FDA warns EnMed MicroAnalytics that it is marketing an unapproved Covid-19 blood sample collection kit.

Device Recognized Standards Modified

[ Price : $8.95]

Federal Register notice: FDA announces a publication containing modifications to the list of standards FDA recognizes for use in p...

Lexicon Pharma Seeks Hearing on Sotagliflozin Rejection

[ Price : $8.95]

Federal Register notice: CDER is proposing to refuse to approve a Lexicon Pharmaceuticals NDA for sotagliflozin oral tablets, 200 ...