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Marketing

OPDP to Study Multiple Indications in TV Ads

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

Human Drugs

Permanent Injunction Against Dietary Supplement Company

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

Biologics

Dupixent sBLA for Pediatric Asthma

FDA accepts for review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on treatment for children aged 6 to ...

Medical Devices

FDA Hit on Slow At-Home Covid Test Approval

Taxpayers Protection Alliance senior fellow Ross Marchand says FDA needs to overcome its aversion to approving rapid home-based Covid-19 tests.

Federal Register

Former Insys Vice President Debarred

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

Federal Register

Physician Debarred Over Role at Internet Pharmacy

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

Medical Devices

EnMed Marketing Unapproved Covid Sample Kit: FDA

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

Federal Register

Device Recognized Standards Modified

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

Federal Register

Lexicon Pharma Seeks Hearing on Sotagliflozin Rejection

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

Federal Register

Device Panel to Review TransMedics Heart System

Federal Register notice: FDA announces a 4/6 advisory committee meeting to review a TransMedics PMA for its Organ Care System (OCS) Heart, a portable ...