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FDA Approves an Edgemont NDA for Fluoxetine 60mg

[ Price : $8.95]

FDA approves an Edgemont Pharmaceutical NDA for fluoxetine tablets 60 mg, the active ingredient in Eli Lilly's Prozac.

Quality System Problems at X-Ray Support

[ Price : $8.95]

FDAs Seattle District Office warns X-Ray Support, Inc. about Quality System and registration violations in its manufacturing of de...

Labeling Content and Format Guidance

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FDA issues a guidance on content and format of specific labeling sections for human Rx drug products and biologicals.

Physical-Chemical Identifier Guidance

[ Price : $8.95]

FDA issues a guidance to help drug manufacturers incorporate physical-chemical identifiers into solid oral dosage forms.

EC Proposes Revised Rx Drug Information Requirements

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The European Commission proposes revising requirements on information that drug companies can give to the public on Rx medicines.

Sprycel May Increase Pulmonary Arterial Hypertension Risk: FDA

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A new FDA safety alert warns that Bristol-Myers Squibb's leukemia drug Sprycel (dasatinib) may increase the risk of pulmonary arte...

NORD Wants Flexible Review Policy

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The National Organization for Rare Disorders calls on FDA to formalize its historic flexibility in reviewing orphan drugs in an ag...

FDA Reporters Speak of Intimidation, Retaliation

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As industry has complained for decades, now journalists say they have to fear intimidation and actual retaliation from FDA unless ...

Advaxis Pre-IND Meeting for HER2 Cancer Therapy

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FDA grants a pre-IND meeting to Advaxis for 11/22 to discuss the initial clinical development plan for ADXS-HER2 and its use in tr...

FDA Clears Canon Retinal Camera

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FDA clears a Canon USA 510(k) for the CR-2 PLUS Digital Non-Mydriatic Retinal Camera.