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Comments Sought on IVD Studies

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a guidance on informed consent for in vitro diagnostic device studies using unident...

Draft Guidance on INDs for Hematopoietic Reconstitution

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Federal Register Notice: FDA releases a draft guidance on INDs for minimally manipulated, unrelated allogeneic placental/umbilical...

CDRH Posts Potential Guidances

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Federal Register Notice: FDA posts a list of possible guidances up for CDRH consideration.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Baxter Healthcare, Cerovene, Customed, Dava, Dynamic Surgery, Glenmark Pharmaceu...

Multiple Device Violations Found in Baxter Inspections

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FDAs Chicago District Office warns Baxter Healthcare over multiple medical device violations at its headquarters and several manuf...

FDA OKs Glaxos Kidney Cancer Drug

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FDA approves GlaxoSmithKlines Votrient (pazopanib) for patients with advanced renal cell carcinoma.

FDA Announces New, Updated Medication Guides

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FDA says new Medication Guides have been published for four drugs.

Cardiac Allograft Gene Profiling Test Guidance

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FDA issues a guidance giving recommendations to manufacturers of cardiac allograft gene expression profiling test systems on prepa...

Comments Sought on CLIA Waivers for IVDs

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Federal Register Notice: FDA seeks comments on collections of information associated with a guidance on CLIA waiver applications f...

Guidance on Cord Blood for Reconstitution

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Federal Register Notice: FDA releases a guidance for manufacturers on minimally manipulated, unrelated allogeneic placental/umbili...