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Brassica Pharma Hit with 10-item FDA-483

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A January inspection of Brassica Pharmas Indian sterile drug manufacturing facility leads to a 10-observation Form FDA-483 that ci...

Suns JAK Inhibitor OKd for Alopecia Areata

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FDA approves a Sun Pharmaceutical Industries NDA for Leqselvi (deuruxolitinib) 8 mg tablets for treating adults with severe alopec...

Pulmonary-Allergy Drugs Panel Renewal

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Federal Register notice: FDA announces the renewal for two years of its Pulmonary-Allergy Drugs Advisory Committee.

Pediatric Committee to Mull Safety of 41 Products

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Federal Register notice: FDA announces a 9/18 Pediatric Advisory Committee meeting that will discuss post-marketing pediatric-focu...

Alert on Compounded Semaglutide Overdoses

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FDA warns about adverse event reports it has received that may be related to overdoses due to dosing errors associated with compou...

FDA Slaps Hold on Diabetes Investigational Drug

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FDA issues a clinical hold on a vTv Therapeutics Phase 3 trial (CATT1) involving cadisegliatin (XXX DE-ITALICIZE XXX)and its use i...

Blog Post on Device AI Lifecycle Model

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A new CDRH blog post outlines key activities that should be taking place during the lifecycle of artificial intelligence-enabled m...

bioMrieux Respiratory/Sore Throat Panel Cleared

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FDA clears a bioMrieux 510(k) for its Biofire Spotfire Respiratory/Sore Throat Panel Mini for detecting five of the most common vi...

Aurobindo Recalls Healthy Living Migraine Relief

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FDA says Aurobindo has recalled one lot of its OTC Healthy Living migraine medication that was distributed through Amazon without ...

VICH Residual Solvents Guidance

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FDA publishes a Veterinary International Conference on Harmonization revised guidance on residual solvents used in animal drugs.