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CBER Cautions Tri-State Biologics

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CBER sends Tri-State Biologics a notice of violation about selling amniotic/chorionic-based injectable products without a valid bi...

Forest Sues Mylan Over Savella ANDA

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Forest sues Mylan over its ANDA for a generic form of Savella (milnacipran) tablets.

Hamburg Promises Increased Cooperation with Device Makers

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During a plenary presentation at an AdvaMed conference, FDA commissioner Margaret Hamburg promises increased cooperation and colla...

FDA Awards Peds Medical Device Grants

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FDA awards more than $3.5 million in grants to seven pediatric medical device consortia to increase development and availability o...

New Arzerra and Rituxan Boxed Warning

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FDA approves a new Boxed Warning for Arzerra and Rituxan about the risk of reactivation of hepatitis B infection.

Sunesis Enrolls 712 in Phase 3 Leukemia Trial

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Sunesis Pharmaceuticals completes enrollment of a Phase 3 VALOR trial of vosaroxin plus cytarabine in first relapsed or refractory...

Guidance on Mobile Medical Apps

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Federal Register Notice: FDA releases a guidance: Mobile Medical Applications.

Orphan Status for Bayer for Hypertension Drug

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FDA grants orphan drug designation to Bayer HealthCare for its Adempas (riociguat) for treating pulmonary arterial hypertension an...

W.S. Badger Recalls Contaminated Sunscreen

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W.S. Badger recalls all lots of 4 oz. SPF 30 Baby Sunscreen Lotion and one lot of its 4 oz. SPF 30 Kids Sunscreen Lotion due to mi...

FDA Tells Firms Ear Drops Are Prescription Drugs

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FDA District Offices warn three companies that their OTC homeopathic ear drops should be marketed as prescription drugs.