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FDA General

CDER/CBER Restarting In-Person Industry Meetings

CDER and CBER say that beginning 2/13 they will restart limited in-person, face-to-face industry meetings.

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Medical Devices

Oracle Technology Guru Named FDA Digital Health Director

Eleven-year Oracle veteran Troy Tazbaz joins FDA as Digital Health Center of Excellence director, replacing Bakul Patel who left the agency last May t...

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Federal Register

Info Collection Revision on PMA Submissions

Federal Register notice: FDA seeks comments on an information collection revision entitled Premarket Approval of Medical Devices.

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Federal Register

Panel to Discuss Non-Rx Naloxone Spray

Federal Register notice: FDA announces a 3/20 joint advisory committee meeting to review an NDA for proposed nonprescription nasal spray for use as an...

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Human Drugs

Lawsuit Against FDA and Livestock/Poultry Antibiotic Use

Several public health advocacy groups sue FDA, challenging its 2021 denial of a citizen petition that sought the withdrawal of medically important ant...

Medical Devices

FDA Funding Opportunity for Pediatric Device Consortia

FDA posts a new funding opportunity for its Pediatric Device Consortia grants program, which is open for applications through 3/29.

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Human Drugs

New Data Support Carvykti sNDA in Multiple Myeloma

Janssen Pharmaceutical says it will submit an NDA supplement for Carvykti (ciltacabtagene autoleucel; cilta-cel) after announcing favorable data from ...

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Human Drugs

Vanda Petitions FDA Over Teva Non-BrailleLabeling

Vanda Pharmaceuticals petitions FDA to revoke the approval of a Teva ANDA for a generic copy of Vandas Hetlioz (tasimelteon) because Tevas product fai...

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Human Drugs

FDA Denies Petition on Jakafi Safety Labeling

FDA denies a 3/2021 petition filed by Loeb & Loeb that asked the agency to take specific actions concerning the adequacy of safety labeling for Incyte...

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FDA General

Eschoo Reelected as Ranking Dem on Health Subcommittee

Democrat members of the House Energy and Commerce Committee vote Rep. Anna G. Eshoo (D-CA) as ranking Democrat on the Health Subcommittee.