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Five-year IT Plan Out for GDUFA

[ Price : $8.95]

FDA releases its five-year GDUFA information technology plan with objectives for five main goals.

Rate Set for Rare Pediatric Priority Review

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Federal Register Notice: FDA announces the fee rate for using a rare pediatric disease priority review voucher for FY 2015.

Prepare for the Worst with Ebola: Goodman

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Former FDAer Jesse Goodman says the nation must prepare for the worst while not panicking now that an Ebola patient has been found...

FDA Strategic Plan Focuses on Increased Product Surveillance

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FDA targets increased activities for detection and surveillance of problems with FDA-regulated products in its just-released five-...

FDA Denies Celgene Thalidomide ANDA Petition

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FDA denies a 2007 Celgene petition asking it not to approve any ANDAs for generic Thalomid.

Pharma Loses in California Drug Disposal Case

[ Price : $8.95]

The U.S. Court of Appeals for the Ninth Circuit rules that efforts by Alameda County, CA to collect disposal costs from drug compa...

Avedro Refiles NDA for Ophthalmic Therapy

[ Price : $8.95]

Avedro resubmits an NDA for the KXL System (riboflavin ophthalmic solution), indicated for treating progressive keratoconus or cor...

Express Diagnostics Inspection Yields QS Issues

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FDAs Minneapolis District Office warns Express Diagnostics International about Quality System problems in its production of drug o...

No Increased Reporting From FDA Drug Alerts: Study

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An AdverseEvents study shows that FDA drug alerts and warnings dont lead to increased adverse events reports on those drugs.

System of Record MAPP Issued

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CDER issues a MAPP documenting its System of Record and Office of Business Informatics responsibilities.