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Osmed Warned About QS Violations

[ Price : $8.95]

FDA warns Osmed GmbH about Quality System and other violations in its manufacturing of a tissue expander.

Post-marketing Violations at Crescendo

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FDAs Los Angeles District Office warns Crescendo Therapeutics of post-marketing adverse drug experience and unapproved new drug vi...

FDA Will Review a BMS/Pfizer NDA for Eliquis

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FDA has accepted for review a Bristol-Myers Squibb/Pfizer NDA for Eliquis for preventing stroke and systemic embolism in atrial fi...

BioTime, OncoCyte Add Former FDA Commish to Boards

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BioTime and subsidiary OncoCyte appoint former FDA commissioner Andrew von Eschenbach to their boards of directors.

Repeat Observations in Integra FDA-483

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FDAs New Jersey District Office releases an FDA-483 detailing eight violations found at Integra LifeSciences.

FDA Will Review Onyx Myeloma Drug NDA

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FDA says it will review an Onyx NDA for carfilzomib to treat some patients with multiple myeloma.

10 Objectionable Conditions Found at Zimmer Facility.

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FDA releases an FDA-483 detailing 10 inspectional observations made at Zimmer, Inc.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Crescendo Therapeutics, Hills Pet Nutrition, Nanoliposomals, Osmed, and Precisio...

FDA Approves Watsons Generic Yaz

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FDA approves a Watson Laboratories ANDA for a generic version of Bayers Yaz oral contraceptive.

Hospira Troubles May Lead to Consent Decree, Analyst Says

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RBC Capital Markets analyst Shibani Malhotra says it is looking more likely that a consent decree will be needed to ensure GMP vio...