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DePuy Synthes Pays $10 Million to Settle Kickback Scheme

[ Price : $8.95]

Johnson & Johnsons DePuy Synthes medical device unit agrees to pay $9.75 million to resolve allegations it violated the False Clai...

Petition Urges FDA to Regulate LED-pulsing Devices

[ Price : $8.95]

A citizen petition by Soft Lights Foundation urges FDA to issue regulations under 21 CFR Part 1040.41 to regulate electromagnetic ...

Petition Seeks Block on Some Tc-99m NDAs

[ Price : $8.95]

A citizen petition asks FDA to refuse to approve any NDA seeking approval of a conventional Technetium-99m (Tc-99m) generator or T...

Advertising Group Hits Novartis on Kisqali DTC Ad

[ Price : $8.95]

The National Advertising Division of BBB National Programs says Novartis should discontinue making certain claims in a direct-to-c...

FDA Updates Listing of Recent Device EUAs

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Federal Register notice: FDA announces the issuance of Emergency Use Authorizations for medical devices related to the Covid19 pub...

Blueprint Medicines sNDA for Ayvakit

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FDA accepts for review a Blueprint Medicines supplemental NDA for Ayvakit (avapritinib) for treating adults with indolent systemic...

Guidance on Ibuprofen Compounding to Help Shortages: FDA

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FDA issues an immediately-in-effect guidance on compounding certain ibuprofen products that is intended to alleviated product shor...

Behavioral Therapy Devices for GI Put into Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies computerized behavioral therapy devices for treating symptoms of gastrointestinal conditio...

Pulsed Light for Dry Eye is Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies intense pulsed light devices for managing dry eye into Class 2 (special controls).

FDA Memo Recommends Califf Order Makenas Withdrawal

[ Price : $8.95]

A just-released FDA memo to commissioner Robert Califf and chief scientist Namandj Bumpus recommends that they order the withdrawa...