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FDA Grants Kamada Orphan Status for Glassia

[ Price : $8.95]

FDA grants Kamada Ltd. an orphan drug designation for Glassia, the companys proprietary human Alpha-1 Antitrypsin for treating Gra...

WV Federal Court Allows Express Warranty Claims

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Attorney John Sullivan says that two rulings in court cases involving Boston Scientifics pelvic mesh appear to make it easier for ...

FDA Awards Contract for New Drug Safety Testing Approaches

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FDA awards a three-year $1.2 million contract to University of Arkansas for Medical Sciences to study new approaches for testing d...

FDA Posts Drug Sampling, Testing Program Details

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FDA describes its process for post-marketing monitoring and testing of finished drugs and active pharmaceutical ingredients to ens...

Cook, Inc., Inspection Finds Quality Issues

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FDAs Detroit District Office warns Cook, Inc., about Quality System violations in its manufacturing of vascular implants and other...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Citrus Fit Weight Loss and Detox Products, Cook, DNG Trading & Milling, Evangeli...

Diamox Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Diamox IV 500 mg base/vial and Diamox tablets, 125 mg and 250 mg were not withdrawn f...

FDA Posts Animal Drug Approvals/Change of Sponsorship

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Federal Register Final rule: FDA amends the animal drug regulations to reflect August approval actions and to change a sponsorship...

Multiple Violations Found in Vitalab Inspection

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FDAs Kansas City District Office warns Vitalab about many violations in its manufacturing and distribution of dietary supplements....

Pull Draft Risk Info Guidance: Patient Group

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Industry and consumer groups say they differ on the value of an FDA draft guidance on communicating new risk information to health...