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Arrayit to File OvaDx Ovarian Cancer Test PMA

[ Price : $8.95]

Arrayit plans a PMA submission for its OvaDx ovarian cancer screening test.

InSite Vision Pain Trial in Ocular Surgery

[ Price : $8.95]

InSite Vision begins a Phase 1/2 clinical trial of ISV-303, a topical anti-inflammatory product intended to reduce the pain and in...

Tootsie Tanner Could Give UV Overdose

[ Price : $8.95]

FDA says owners should stop using the Tootsie Tanner foot tanning device due to a risk of ultraviolet radiation overexposure.

Potential Problems with Some Med Pro Mammograms

[ Price : $8.95]

FDA says problems have been found with mammograms from Med Pro Imaging in Plantation, FL.

FDA Mum on Employees Charges of New Unsafe Device OKs

[ Price : $8.95]

Again balking at the discomforts of transparency, FDA maintains its traditional silence on new employee allegations in the New Yor...

Recent Federal Register Notices

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Federal Register notices for 8/13-8/19 are posted.

FDA Mulls Data on Stalevo and Cardivascular Risk

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FDA says it is reviewing clinical trial data that suggest patients taking the Novartis Parkinson's therapy Stalevo (a combination ...

Gilead Receives Notice on ANDA for Hepsera

[ Price : $8.95]

Gilead Sciences says it has received a Hatch-Waxman Paragraph 4 certification notice letter advising that Sigmapharm Laboratories ...

FDA Clears Hyperbaric Chamber Operating Software

[ Price : $8.95]

FDA clears an Environmental Tectonics Biomedical Systems 510(k) for OSCAR (Operating System for Control And Recording).

Impax Initiates Vytorin Patent Challenge

[ Price : $8.95]

Impax initiates a challenge to patents listed by MSP Singapore for Vytorin, 10 mg/80mg.