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FDA Tentatively Approves Matrix PEPFAR Drugs

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FDA tentatively approves Matrix Laboratories HIV/AIDS drug cocktail for use outside the U.S. in the PEPFAR program.

FDA Changes Coming Under PIC/S Inspectorate Role

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FDA Office of Regulatory Affairs strategic initiatives executive director Brenda Holman updates a regulatory conference on agency ...

CDER Pilot Program Speeds Up Drug Recall Postings

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CDER begins a new pilot program where it now posts drug recall information in its weekly Enforcement Report before the recall has ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Biolab Company, Chronicity, Covenant HealthCare, Eagle Diagnostics, Sam-Go Produ...

5 Companies Report Paclitaxel Delays

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FDA says five companies are reporting shortages in paclitaxel injections.

FDA, Orexigen Agree on Contrave Trial

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FDA and Orexigen agree on a cardiovascular risk trial for the companys Contrave weight loss drug.

Updated CPG on Marketing Unapproved Drugs

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FDA issues a compliance policy guide clarifying how it is exercising enforcement discretion for unapproved drugs introduced into t...

Changes to Patent Law Approved

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President Obama signs legislation reforming patent law.

FDA's Autor Preparing the Agency for 'Mutual Reliance'

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FDA deputy commissioner for global regulatory operations and policy Deb Autor says mutual reliance or recognition of inspection re...

FDA and Globalization Just the Facts

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FDA deputy commissioner for global regulatory operations and policy Deb Autor provides the latest numbers on how globalization has...