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Sato Pharmaceutical FDA-483 Out

[ Price : $8.95]

FDA releases the form FDA-483 with 10 observations from an inspection at Japans Sato Pharmaceutical over-the-counter drug manufact...

Draft Guide on Blood Pressure Monitoring Sensors

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FDA issues a draft guidance detailing expectations for how makers of cuffless, non-invasive blood pressure monitoring devices shou...

FDA Drug Ad Enforcement Letters Hit 25-Year High

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Six King & Spalding attorneys analyze FDA advertising and promotion enforcement letters for drugs and medical devices issued in 20...

Corcept Reports Promising Survival Data for Ovarian Cancer Drug

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As its NDA is currently under FDA review, Corcept Therapeutics says its experimental drug relacorilant met the overall survival pr...

6 Observations in Lupin Nagpur Inspection

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FDA releases the form FDA-483 with six observations from an inspection at the Lupin sterile manufacturing facility in Nagpur, Indi...

Alert on Compromised Wound/Burn Dressings

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FDA issues an early alert warning of a potentially high-risk issue involving certain wound and burn dressings made by Integra Life...

Orphan Status for Experimental Myelofibrosis Therapy

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FDA grants Opna Bio an orphan drug designation for its investigational treatment OPN-2853 (zavabresib) for treating myelofibrosis.

Drug Shortage Announcements Can Lead to Protective Purchasing: USP

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A United States Pharmacopoeia study finds that protective purchasing following information on drug shortages can adversely affect ...

FDA Push to Move More Drugs to OTC Status

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FDA commissioner Marty Makary discusses upcoming actions to encourage more prescription-to-over-the-counter drug switches.

Cogent Bio Plans NDA for Bezuclastinib

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Cogent Biosciences says FDA has agreed to accept the companys planned NDA for cancer drug bezuclastinib under the agencys Real-Tim...