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Centocor Ortho Biotech Submits sBLA for RA Drug

[ Price : $8.95]

Centocor Ortho Biotech submits a supplemental BLA to FDA to expand the physician labeling for its rheumatoid arthritis drug Simpon...

Advisors Recommend Hologic Mammography System

[ Price : $8.95]

Members of FDAs Radiation Devices Panel recommend that Hologics Selenia breast cancer detection system is safe and effective.

Guided Therapeutics Files PMA for Cervical Scanner

[ Price : $8.95]

Guided Therapeutics, Inc. files a PMA with FDA for the LightTouch Cervical Scanner for patients at risk for cervical cancer.

Regulatory Science Projects Getting $9.4 Million

[ Price : $8.95]

FDA and NIH are funding four regulatory science research projects over the next three years.

Clazosertan Trial Misses Endpoint

[ Price : $8.95]

Trial results of Actelions clazosertain in patients with aneurysmal subarachnoid hemorrhage were not significant in favor of the d...

FTC Wants FDA Pre-approval of POM Wonderful Claims

[ Price : $8.95]

FTC says it wants FDA pre-approval of any future health benefit claims to be made by POM Wonderful for its pomegranate juice produ...

Docket Number Added in Dental Panel Notice

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Federal Register Notice: FDA amends a 6/11 notice on the upcoming meeting of the Dental Products Panel to add a docket number to A...

CDRH Adds Advertising and Policy Staff

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CDRH ramps up its Office of Compliance promotion and advertising staff, adding two regulatory reviewers to help tackle the workloa...

FDA Approves Allergan's Eye Drug Ozurdex

[ Price : $8.95]

FDA approves an Allergan NDA for Ozurdex (dexamethasone intravitreal implant) 0.7 mg for treating non-infectious ocular inflammati...

Info on Device Approval Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on premarket approval of devices to the Office of Manage...