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FDA Orphan Status for Burzynski Cancer Therapy

[ Price : $8.95]

FDA grants an orphan drug designation to the controversial Burzynski Research Institute for its antineoplaston A10 and antineoplas...

FDA Complete Response on MedImmune BLA

[ Price : $8.95]

FDA issues MedImmune a complete response letter on its BLA for motavizumab, indicated for preventing serious respiratory syncytial...

FDA Upholds Reference Drug Change Requirement

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FDA upholds its reference-listed drug change policy in a case involving Osmoticas NDA for venlafaxine HCl extended-release tablets...

Guilty Plea in Device Misbranding Case

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U.S. attorney Michael Sullivan says a medical device company manager pleaded guilty to making a false statement and misbranding.

Guidance on Data Retention on Withdrawn Trial Participants

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Federal Register Notice: FDA releases a guidance, Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials.

Committee to Evaluate Novartis Malaria Drug

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FDA tells the Anti-infective Advisory Committee it sees mild to moderate adverse events in Novartis malaria drug Coartem.

Combination Product Approval Process is Challenging

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Microtest Laboratories president Steven Richter says manufacturers of combination products will be challenged to keep up with incr...

Mylan Sued Over ANDA for Generic Amrix

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Cephalon, Eurand, and Anesta AG file suit against Mylan Pharmaceuticals over its ANDA for a generic copy of muscle relaxant Amrix.

Old Antibiotic Patent Information Guidance Out

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CDER issues a draft guidance on submitting patent information for certain old antibiotics.

FDA Priority Review for Zevalin sBLA

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FDA grants a priority review for a Cell Therapeutics supplemental BLA for Zevalin, indicated as first line consolidation therapy f...