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Federal Register

Dermatologic/Ophthalmic Drugs Panel Renewal

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

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Federal Register

FDA Permanently Debars Analay Rico

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

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Human Drugs

Bipartisan Bill on Provisional FDA Approvals

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

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FDA General

FDA Needs New Policies for AI: Gottlieb

Former FDA commissioner Scott Gottlieb and his former chief of staff Lauren Silvis say FDA needs new policies geared toward integrating artificial int...

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Medical Devices

FDA Alert on Oxygenator Recall

FDA alerts health care providers and facilities on the use of oxygenators in extracorporeal circulation following a recent recall by Getinge/Maquet of...

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Human Drugs

Panel Backs Full Approval of Alzheimers Drug

An FDA advisory committee votes 6 to 0 that data from the Phase 3 CLARITY AD trial verified the clinical benefit of Eisai/Biogens Leqembi (lecanemab) ...

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Medical Devices

SurGenTec Sacroiliac Joint Fusion Device Cleared

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

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Human Drugs

FDA Sees Need to Better Address Drug Shortages

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

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Human Drugs

Oral Contraceptive Drug Interaction Guidance

FDA publishes a guidance to help IND and NDA sponsors evaluate the drug-drug interaction effects of their investigational drugs on combined oral contr...

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Human Drugs

Keytruda sBLA for Biliary Tract Cancer

FDA accepts for review a Merck supplemental BLA for Keytruda in combination with standard-of-care chemotherapy for treating patients with biliary trac...