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FDA Sets Priority Review for Benlysta

[ Price : $8.95]

FDA grants Human Genome Sciences a priority review for its BLA on Benlysta (belimumab) for treating systemic lupus erythematosus.

Comments Sought on Communication Studies for CVM Products

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on communication studies for CVM-regulated products.

FDA Clears Fenwal Software Upgrade

[ Price : $8.95]

FDA clears a Fenwal 510(k) for a new software release for its Autopheresis-C system used to collect plasma from donors.

HHS Touts New Approach to Medical Countermeasures

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HHS releases a report calling for more resources for FDA to approve new medical countermeasure drugs, vaccines, and devices more q...

Public Meeting on New Science at CDRH

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Federal Register Notice: FDA plans a public meeting 2/9/10 on incorporating new science into regulatory decisionmaking within CDRH...

ISTA Files sNDA for Ocular Drug

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ISTA Pharmaceuticals submits a supplemental NDA for once-daily bromfenac ophthalmic solution as a treatment for ocular inflammatio...

FDA OKs new COPD Indication for Spiriva

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FDA approves Boehringer Ingelheim Pharmaceuticals Spiriva HandiHaler (tiotropium bromide inhalation powder) for reducing exacerbat...

Companies Should Re-train on DDMAC 'Rules'

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Attorney Arnold Friede says that drug companies need to be aware of the rules that CDERs DDMAC applies when evaluating presentatio...

Roche Discontinues Zenapax Production

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Roche decides to discontinue production of Zenapax (daclizumab) sterile concentrate for injection, indicated for prophylaxis of a...

Early ANDA Submissions Cause Problems for Courts, FDA

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Attorney Kurt Karst says that FDA and federal courts are concerned that companies filing ANDAs many years before they expect to be...