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FDA Warning Letters on Chinese Syringes

[ Price : $8.95]

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

FDA OKs Chronic Rhinosinusitis Nasal Spray

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FDA approves an Optinose NDA for Xhance (fluticasone propionate) nasal spray for treating chronic rhinosinusitis without nasal pol...

FDA Cites GMPs in Abeona Inspection

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FDA issues a Form 483 after it finishes a pre-license inspection of Abeonas Cleveland, OH manufacturing facility concerning the co...

Guide on Animal Drug Mfg. Batches

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FDA releases a draft guidance entitled Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.

Date Correction in Alzheimers Guidance

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

Biotronik Breakthrough Status for Freesolve Device

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

GSK Reports Favorable Jemperli Phase 3 Data

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

Eugia Inspection Results in 7-Item FDA 483

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

Bayers Aliqopa Withdrawn Over Failed Confirmation

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

Guidance on Generic Drug Controlled Correspondence

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