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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Guidance on Data Retention on Withdrawn Trial Participants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CDER issues a draft guidance on submitting patent information for certain old antibiotics.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...

Lilly Withdraws Cymbalta sNDA for Pain

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Eli Lilly withdraws a supplemental NDA for Cymbalta (duloxetine HCl) seeking a new indication for managing chronic pain.

FDA OKs Elanco Animal NADA for Turkey Feed

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Federal Register Final rule: FDA approves an Elanco Animal Health NADA for use of ractopamine hydrochloride to make medicated feed...

Time Changed on Pediatric Ethics Subcommittee Meeting

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Federal Register Notice: FDA changes the time for public oral presentations in its Pediatric Ethics Subcommittee meeting scheduled...