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FDA OKs Amneals Generic Anti-acid

[ Price : $8.95]

FDA approves an Amneal Pharmaceuticals ANDA for nizatidine oral solution, 15 mg/mL, a therapeutic equivalent of Braintree Labs Axi...

GSK Warns of Lexiva and Heart Attack

[ Price : $8.95]

GlaxoSmithKline says it has modified Lexivas labeling to highlight concerns about heart attack in HIV infected adults treated with...

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

[ Price : $8.95]

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

Mesantoin Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Mesantoin (mephenytoin) tablets, 100 mg, were not withdrawn for reasons of safety or ...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FDA issues a draft guidance with recommendations to facilitate developing immune assays for assessing therapeutic protein immunoge...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.

Journalism Groups Seek End to FDA Media Controls

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Major journalism groups ask FDAs Transparency Task Force to set a government-wide example and end restrictions on reporters coveri...

FDA Lifts Clinical Hold on CytRx Sclerosis Drug

[ Price : $8.95]

FDA accepts a new trial protocol and lifts its clinical hold on CytRxs arimoclomol for treating ALS.

Update Federal Clinical Trial Policy, Regulations: Paper

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A Seton Hall Law School white paper says that regulations and policy governing clinical trial financial arrangements with investig...