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FDA Approves Ascension's Total Shoulder System

[ Price : $8.95]

FDA approves an Ascension Orthopedics PMA for the Titan Modular Total Shoulder System.

Device Submissions Up, Review Times Down

[ Price : $8.95]

CDRHs Office of Device Evaluation says it is making excellent progress in implementing MDUFMA and meeting its performance goals.

FDA Meeting With BDSI/Meda Looks to Revise Pain Drug REMS

[ Price : $8.95]

FDA gives positive comments to a BioDelivery Sciences International (BDSI) and Meda proposed revision to a risk evaluation and mit...

Date Added to Pristiq Review Period Notice

[ Price : $8.95]

Federal Register Notice: FDA adds a date to an 8/31 Federal Register announcing the determination of a regulatory review period fo...

Guidance on Impact-Resistant Lenses

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance, Impact-Resistant Lenses: Questions and Answers.

Guide on New Animal Drugs for Minor Uses/Species

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Federal Register Notice: FDA releases a guidance, Small Entities Compliance Guide Designation of New Animal Drugs for Minor Uses o...

Office of Womens Health Update Planned

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Federal Register Notice: FDA plans a meeting 9/22, Office of Women's Health Update in Washington, DC.

FDA Improves in Best Govt. Places to Work List

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FDA improves its ranking to No. 89 among 223 federal agencies surveyed for federal employee satisfaction and commitment in the ann...

FDA Approves Abbott Hepatitis B Assay

[ Price : $8.95]

FDA approves an Abbott PMA for the Abbott RealTime HBV assay for measuring viral load hepatitis B virus patients blood.

FDA Clears Unilife Tuberculin Syringe

[ Price : $8.95]

FDA clears a Unilife Corp. 510(k) for the Unitract Tuberculin Syringe, claimed to help prevent transmission of blood-borne disease...