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FDA OKs Cross Vetpharm ANADA for Parasites

[ Price : $8.95]

Federal Register Final rule: FDA approves a Cross Vetpharma ANADA for an invermectin injectable solution for treating parasites in...

Info on DTC Promos Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on an experimenta...

Panel to Discuss 2 PMAs for Atrial Fibrillation

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 10/26-27 to discuss an AtriCure PMA and a Medtronic PMA t...

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 ...

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Federal Register Notice: FDA releases a draft guidance on self-selection studies for nonprescription drug products.