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FDA OKs Watsons BPH Drug

[ Price : $8.95]

FDA approves Watson Pharmaceuticals Rapaflo (silodosin), an alpha blocker indicated for treating benign prostatic hyperplasia.

Hi-Tech Ephedra Seizure Upheld

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The 11th circuit court of appeals says FDA properly seized Hi-Tech Pharmaceuticals ephedra supplements under its final rule bannin...

Cellular, Gene Product Potency Test Guidance Out

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FDA issues a guidance to help cellular and gene product manufacturers develop potency tests to support INDs and BLAs.

Guidance on Cellular, Gene Potency Tests

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Federal Register Notice: FDA releases a draft guidance on potency tests for cellular and gene therapy products.

OMB OKs Biologics Cooperative Mfg. Info

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Federal Register Notice: OMB approves an FDA collection of information on a guidance on cooperative manufacturing for licensed bio...

FDA Sends FDA Recall Info to OMB

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Federal Register Notice: FDA submits to OMB a collection of information on FDA recall regulations.

Science Board to Hear Bisphenol Assessment

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Federal Register Notice: The Science Board to FDA will meet 10/31 to hear an assessment of Bisphenol A for use in food contact app...

FDA Approves New Injection Site for Risperdal

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FDA approves a new injection site the arms deltoid muscle for Janssens schizophrenia drug Risperdal.

FDA Sets Kynapid End-of-review Meeting

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FDA will hold an end-of-review meeting 11/14 with Cardiome and Astellas officials on their NDA for Kynapid.

Blood Establishments Can Distribute Certain Drugs

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Federal Register Final rule: FDA amends its regulations to allow certain blood establishments and hemophilia diagnostic centers to...