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FDA Funds C-Path Genetic Test Evaluations

[ Price : $8.95]

FDA awards a $675,000 grant to the Critical Path Institute to allow scientists to evaluate genetic tests for determining existing ...

Uroplastys PMA on Urinary Incontinence Bulking Agent Approvable

[ Price : $8.95]

FDA issues Uroplasty, Inc. an approvable letter for its PMA on Macroplastique implants intended to treat female stress urinary inc...

MDS Pharma Research Studies Faulted Again by FDA

[ Price : $8.95]

A scathing FDA untitled letter provides a glimpse into the troubles contract research organization MDS Pharma is having in trying ...

FDA Outlines Requirements for Tissue Processors

[ Price : $8.95]

A new FDA guidance outlines responsibilities for firms to comply with current good tissue practice requirements when they enter in...

Leading Causes of Drug Recalls

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CDERs Joseph Famulare cites recent statistics on drug recalls, and identifies specific problem areas in production and quality sys...

FDA Plans Follow-up Audit of Medtronic GMP Woes

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FDA plans a follow-up inspection of a Medtronic neurological devices manufacturing facility after the agency received limited info...

Sue FDA with Me, Levothyroxine Impurities Fighter Asks USP

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Retired FDA chemist Burton Appleton asks USP to help him appeal last months federal court loss to FDA on levothyroxine documents, ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Actavis Totowa, Frye Health Systems, Hamricks, LGS Technologies, Medtronic, and ...

Guidance on Drug Interaction Studies

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Federal Register Notice: FDA releases a draft guidance on drug interaction studies, which details study design and implications fo...

Mylan Gains Approval for Generic Topamax

[ Price : $8.95]

FDA approves a Mylan Pharmaceuticals ANDA for topiramate tablets, 25 mg, 100 mg and 200 mg, a generic version of Ortho-McNeil's To...