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FDA OKs Boston Scientific Ventricular Pacing Software

[ Price : $8.95]

FDA approves the use of new Boston Scientific Corp.s software to enable its Left Ventricular Offset feature in Contak Renewal card...

FDA OKs MediGene NDA for Genital Warts

[ Price : $8.95]

FDA approves a MediGene NDA for Polyphenon E ointment, indicated for treating external genital and perianal warts.

AstraZeneca Reports Two Seroquel Subpoenas

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AstraZeneca says it is replying to subpoenas from the California and Alaska attorneys general on Seroquel safety, efficacy, and ma...

FDA Workshop on Marketed Unapproved Drugs

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FDA schedules a 1/9/07 public workshop on methods by which unapproved drugs can be legally marketed.

Banner Warned on CGMP Deviations

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FDAs Atlanta District Office warns Banner Pharmacaps about CGMP violations.

FDA Proposes Hemostatic Device into Class 2

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Federal Register Proposed rule: FDA proposes to reclassifies the absorbable hemostatic device intended to produce hemostasis into ...

CGMP Problems Found at Dialysis Services

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FDAs New Orleans District Office warns Dialysis Services Inc. on CGMP violations.

FDA Approvable Letter on Avanir NDA

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FDA issues Avanir Pharmaceuticals an approvable letter for Zenvia, indicated for treating involuntary emotional expression disorde...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Banner Pharmacaps, Dialysis Services, David A. Lein, and Radiometer America.

FDA OKs Pfizer API Comparability Protocol

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FDA backs Pfizer plan for comparability testing on APIs being outsourced to two Asian firms.