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FDA Wants More Aveed Data

[ Price : $8.95]

An FDA complete response letter on Endos Aveed testosterone injection asks for more adverse event information and a revised REMS.

Public Citizen Again Asks for Meridia Ban

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Public Citizen again calls on FDA to immediately pull Abbotts Meridia from the U.S. market.

Mesantoin Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Mesantoin (mephenytoin) tablets, 100 mg, were not withdrawn for reasons of safety or ...

Immunogenicity Testing Assay Development Guidance Out

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FDA issues a draft guidance with recommendations to facilitate developing immune assays for assessing therapeutic protein immunoge...

FDA Reminder on Valproate Concerns

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FDA posts information for healthcare professionals on birth defects associated with exposure to valproate sodium during pregnancy.

PDUFA Goals Back on Track, Jenkins Says

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Office of New Drugs director John Jenkins says a two-year hiring push at CDER has added enough new staff that the Center is now ba...

WLF Backs Allergan Off-label Suit

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Washington Legal Foundation and three patient groups say they support Allergans challenge to FDA regulations preventing it from sh...

FDA, Genzyme Agree to Lumizyme Manufacturing Change

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Genzyme says it will ask FDA to approve manufacturing Lumizyne at a larger bioreactor scale to avoid problems at its Allston, MA, ...

Abilify Discmelt Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Abilify Discmelt orally disintegrating tablets, 20 and 30 mg were not withdrawn from ...

FDA Clears Spectranetics VisiSheath Dilator Sheath

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FDA clears a Spectranetics Corp. 510(k) for its VisiSheath Dilator device for dilating tissue surrounding cardiac leads or as an e...