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Human Drugs

FDA Warning Letters on Chinese Syringes

FDA sends Warning Letters to Jiangsu Shenli Medical Production Co. Ltd, a China-based plastic syringe manufacturer, and Medline Industries and Sol-Mil...

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Human Drugs

FDA OKs Chronic Rhinosinusitis Nasal Spray

FDA approves an Optinose NDA for Xhance (fluticasone propionate) nasal spray for treating chronic rhinosinusitis without nasal polyps in patients 18 y...

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Human Drugs

FDA Cites GMPs in Abeona Inspection

FDA issues a Form 483 after it finishes a pre-license inspection of Abeonas Cleveland, OH manufacturing facility concerning the companys BLA for pz-ce...

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Animal Drugs

Guide on Animal Drug Mfg. Batches

FDA releases a draft guidance entitled Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.

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Federal Register

Date Correction in Alzheimers Guidance

Federal Register notice: FDA corrects a date in a 3/12 notice announcing the availability of a guidance entitled Early Alzheimers Disease: Developing ...

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Human Drugs

Biotronik Breakthrough Status for Freesolve Device

FDA grants Biotronik a beakthrough device designation for the Freesolve below-the-knee resorbable magnesium scaffold, intended for use in individuals ...

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Human Drugs

GSK Reports Favorable Jemperli Phase 3 Data

GSK reports favorable overall survival and progression-free survival data in a Phase 3 trial involving Jemperli (dostarlimab) in adult patients with p...

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Human Drugs

Eugia Inspection Results in 7-Item FDA 483

A 2/29-completed FDA inspection of Eugia SEZ Private Ltd.s Telangana, India sterile drug manufacturing facility results in a seven-item Form FDA 483.

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Federal Register

Bayers Aliqopa Withdrawn Over Failed Confirmation

Federal Register notice: FDA withdraws the approval of Bayers NDA for Aliqopa (copanlisib) in response to a failed confirmatory trial.

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Federal Register

Guidance on Generic Drug Controlled Correspondence

FDA posts a final guidance entitled Controlled Correspondence Related to Generic Drug Development.