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5 Companies Report Paclitaxel Delays

[ Price : $8.95]

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.

United Contact Lens Not Registered: FDA

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FDAs Pacific Region warns United Contact Lens about registration and Quality System violations in its manufacture of soft contact ...

CGMP Problems Found at Yag-Mag, India API Plant

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FDA warns Yag-Mag Labs in India about CGMP and registration violations in its manufacture of active pharmaceutical ingredients.

Comments Sought on Animal Drug User Fee Act

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Federal Register Notice: FDA seeks comments on the Animal Drug User Fee Act program.

Meeting on Animal Drug User Fees

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Federal Register Notice: FDA plans a public meeting 11/7 on the Animal Drug User Fee Act.

MRI Safety Workshop Slated

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Federal Register Notice: FDA plans a public workshop 10/25-26 on MRI safety.

FDA OKs Cross Vetpharm ANADA for Parasites

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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...