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Bacitracin Withdrawn Due to Safety: FDA

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Federal Register notice: FDA determines that intramuscular antibiotic bacitracin for injection, 10,000 units/vial and 50,000 units...

Akorn Pays $7.9 Million to Resolve False Claims Suit

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Akorn pays $7.9 million to resolve allegations that it caused Medicare to submit false claims by delaying an Rx to OTC switch for ...

Top FDA-483, Warning Letter Observations

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A MasterControl white paper lists the processes involved in the most common FDA medical device observations and Warning Letters.

FDA Grants, Denies Catalyst Amifampridine Petition

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FDA grants in part and declines in part a Catalyst Pharmaceuticals petition on using amifampridine to treat congenital myasthenic ...

Novartis Wants Restrictions on Entresto ANDAs

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Novartis asks FDA not to approve ANDAs seeking to produce a generic form of its Entresto under specific conditions.

Panel to Review Pulse Oximeter Accuracy

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Federal Register Notice: FDA announces an 11/1 Advisory Committee meeting to discuss ongoing concerns that pulse oximeters may be ...

FDA Challenges Illicit Trade Workshop Attendees

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FDA associate commissioner Mark Abdoo calls for greater collaborative efforts worldwide to combat illicit trade in healthcare prod...

Baxter Clearlink Solution Set Recall is Class 1

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FDA says Baxter Healthcares recall of its Clearlink Basic Solution Sets with Duovent is Class 1.

Regulatory Review Period for Caplyta

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Intra-Cellular Therapies Ca...

Advisors to Discuss Pulse Oximeter Accuracy

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FDA says the Anesthesiology and Respiratory Therapy Devices Panel will meet virtually on 11/1 to discuss issues of potential pulse...