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Vyaire Medical Gains Ventilator Clearance

[ Price : $8.95]

FDA clears a Vyaire Medical 510(k) for the bellavista 1000e ventilator.

Cell/Tissue Product eSubmission Instructions

[ Price : $8.95]

CBER posts Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS).

8 FDA Info Collections Gain OMB Approval

[ Price : $8.95]

Federal Register notice: FDA posts a list of eight information collections that have been approved by OMB.

CDER Office of New Drugs Reorganization in Phase 2

[ Price : $8.95]

CDER says reorganization of the Office of New Drugs moved into Phase 2 11/4.

Innoveix FDA-483 Released

[ Price : $8.95]

FDA releases an FDA-483 with seven observations issued following an inspection at Innoveix Pharmaceuticals.

Pfizer Sees Rebate Issue Blocking Biosimilar Use

[ Price : $8.95]

Biopharma Reporter says that Pfizer CEO Albert Bourta is leading the effort to reform drug company rebates to payers that he says ...

FDA Web Page on Digital Health Reg Policies

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FDA launches a new Web page that encourages firms to inquire about the agencys current policies on digital health products.

Allergenic Products Advisory Committee Needs Rep

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Federal Register notice: FDA seeks industry organizations to participate in selecting nonvoting industry representative to serve o...

CGMP Violations at Chinas Bingbing Pharmaceutical

[ Price : $8.95]

FDA warns Chinas Bingbing Pharmaceutical Co. about CGMP violations in its production of finished drugs.

Drugs Approved With Manufacturing Issues: Kaiser

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A Kaiser Health News special report says FDA sometimes approves expensive innovative branded drugs despite manufacturing issues fo...