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SurGenTec Sacroiliac Joint Fusion Device Cleared

[ Price : $8.95]

FDA clears a SurGenTec 510(k) for its TiLink-L Sacroiliac Joint Fusion System.

Guide on Contraceptive Drug Interaction Studies

[ Price : $8.95]

Federal Register notice: FDA posts a final guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives....

Dermatologic/Ophthalmic Drugs Panel Renewal

[ Price : $8.95]

Federal Register notice: FDA announces the renewal of its Dermatologic and Ophthalmic Drugs Advisory Committee for an additional t...

FDA Permanently Debars Analay Rico

[ Price : $8.95]

Federal Register notice: FDA issues an order to permanently debar Analay Rico from providing services in any capacity related to a...

Bipartisan Bill on Provisional FDA Approvals

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A group of bipartisan senators introduce the Promising Pathway Act, a bill to help Americans with amyotrophic lateral sclerosis (A...

Create One PPI Guidance for all Products: Novartis

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Novartis urges FDA to broaden its proposal on patient preference information beyond medical devices.

Assessing GDUFA User Fees Guidance

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FDA publishes a guidance with specifics about changes to user fees imposed under the GDUFA 3 reauthorization in 2022.

FDA OKs Novaliq Dry Eye Drug

[ Price : $8.95]

FDA approves a Novaliq NDA for Vevye (cyclosporine ophthalmic solution) 0.1% for treating the signs and symptoms of dry eye diseas...

FDA Ups Pediatric Exclusivity Requirements: Attorneys

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Two SheppardMullin attorneys describe how two recent FDA guidances on pediatric drug development will tighten eligibility for pedi...

FDA Sees Need to Better Address Drug Shortages

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FDA says that while drug shortages have declined since 2011, there still are needs to be addressed to help the agency prevent or m...