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Pfizer Pulling Dalbavancin NDA

[ Price : $8.95]

Pfizer says it will withdraw its dalbavancin NDA and conduct another Phase 3 trial to obtain additional data for a future submissi...

Genzyme Recalls Thymoglobulin Lot

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Genzyme recalls one lot of Thymoglobulin that failed stability testing.

Tequin Was Withdrawn for S&E

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Federal Register Notice: FDA determines that Tequin tablets, injection, and oral suspension were withdrawn from sale for reasons o...

Modified Device Standards List Published

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Federal Register Notice: FDA releases, Modifications to the List of Recognized Standards, Recognition List Number: 020, for aid de...

FDA, UPenn Sign MOU

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Federal Register Notice: FDA provides notice of a memorandum of understanding between FDA and the University of Pennsylvania, whic...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Fall Prevention Technologies, Gregory Gardiziola, Sgarlato Labs, and Bruce Ziran...

FDA Releasing Drug Process Validation Guidance Soon

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CDER Division of Manufacturing and Product Quality team leader Brian Hasselbalch tells an industry conference that a draft guidanc...

Public Meeting on Clinical Research

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Federal Register Notice: FDA Dallas District and the Society of Clinical Research Associates will hold a workshop 11/19-20 on FDA ...

Vaccine Development Guidance Out

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FDA issues a guidance to help sponsors develop vaccines to protect against global infectious diseases.

Ortho Biotech Submits Doxil sNDA

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Ortho Biotech submits an sNDA to FDA for a new indication for Doxil in combination with Taxotere.