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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.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Aarti Drugs, Agila Specialties, Fenwal, Homeolab, Insight Pharmaceuticals, Medic...

Stakeholders See Ways to Strengthen REMS Communication

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Stakeholders recommend ways to best communicate REMS information to prescribers and patients.

Oxygen Bio Submits Studies on Oxygen Carrier to FDA

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Oxygen Biotherapeutics responds to an FDA clinical hold with results from two series of animal studies for its intravenous oxygen ...

Report on Observational Studies Workshop

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The Institute of Medicine publishes a report on a two-day workshop on observational studies in clinical research.

Violations Found at Fenwal Puerto Rico Facility

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FDAs San Juan District Office warns Fenwal about violations found in an inspection at a Puerto Rico drug and medical device manufa...

Stakeholders Want Terms in Inspection Draft Guidance Defined

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Stakeholders ask FDA to clarify how it will determine whether facility actions that delay or limit an agency inspection are unreas...