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FDA Orphan Status for BioVie Ascites Therapy

[ Price : $8.95]

FDA grants BioVie an orphan drug designation for BIV201 for treating ascites due to all causes except cancer.

FDA Clears GE MAGiC MRI Technology

[ Price : $8.95]

GE Healthcare gains 510(k) clearance for MAGiC (Magnetic Resonance Image Compilation), which is a customized version of SyntheticM...

FDA Draft Guide on 510(k) 3rd-party Reviews

[ Price : $8.95]

FDA posts a draft guidance on 510(k) Third Party Review Program that describes harmonization efforts, such as incorporating elemen...

FDA Posts Inspection Report Involving Theranos Test

[ Price : $8.95]

FDA posts a one-page Form-483 from an inspection last month at troubled blood diagnostic firm Theranos.

Guidance on Tobacco Products Document Submission

[ Price : $8.95]

Federal Register Notice: FDA releases a revised draft guidance: Health Document Submission Requirements for Tobacco Products.

Guidance on Planning/Design of Multi-Regional Trials

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance entitled E17 General Principles for Planning and Design of Multi-Regional C...

Blood Products Panel to Meet

[ Price : $8.95]

Federal Register Notice: FDA plans a meeting of the Blood Products Advisory Committee 11/17 to discuss topics such as iron deficie...

Board to Center for Toxicological Research to Meet

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Federal Register Notice: FDA plans a meeting of the Science Advisory Board to the National Center for Toxicological Research 11/1-...

FDA Removes Civil Money Penalties Info from Regs

[ Price : $8.95]

Federal Register Final rule: FDA removes from its regulations the maximum civil money penalties table in order to comply with the ...

Novo Nordisk Recalls 6 Lots of GlucaGen HypoKit

[ Price : $8.95]

Novo Nordisk recalls six batches of its GlucaGen HypoKit due to two customer complaints involving detached needles on the syringe ...