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Updated IT Plan Published

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Federal Register Notice: FDA updates its information technology plan to improve the automation of business processes that support ...

Office of Medical Policy Now a Super Office

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CDER director Janet Woodcock says the Office of Medical Policy is now a Super Office that includes a new Office of Medical Policy ...

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...

FDA Approves New Prolia Indications

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FDA approves two additional indications for men and women for Amgens Prolia

Sun Subsidiary Gets FDA Approval

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FDA says that Sun Pharmas Cranberry, NJ, manufacturing facility passed a reinspection and resolved earlier quality issues.

FDA OKs Merial NADA for Bovine Respiratory Disease

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Federal Register Final rule: FDA approves a Merial Ltd. NADA for use of gamithromycin injectable for managing bovine respiratory d...

FDA Updates Progesterone Residues Regs in Cattle/Sheep

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Federal Register Final rule: FDA updates the allowable progesterone residues in edible tissues of cattle and sheep in the animal d...

Guidance on Self-Selection Studies for Non-Rx Drugs

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Federal Register Notice: FDA releases a draft guidance on self-selection studies for nonprescription drug products.