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Latest FDA News and Information
FDA approves generic versions of blood thinner Plavix
The U.S. Food and Drug Administration today approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by... read more
FDA expands use for FilmArray Respiratory Panel
The U.S. Food and Drug Administration today expanded the use for the FilmArray Respiratory Panel, the first test that can simultaneously detect both viral and bacterial causes of respiratory... read more
FDA issues alert on potential dangers of unproven treatment for multiple sclerosis
The U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called ?liberation therapy?... read more
FDA proposal aims to help reduce unnecessary radiation exposure for children
Today, the U.S. Food and Drug Administration announced that it is seeking public comment on a proposal encouraging manufacturers to consider the safety of children in the design of... read more
Food and Drug Adminstration (FDA): CDRHNew
Upcoming Webinar on Hearing Aids: The Basic Information You Need to Know (5/23/12)
Learn more Wednesday, May 23, 2012 at 2:00 p.m. ET, when FDA's Center for Devices and Radiological Health (CDRH) will host a 30-minute Webinar to discuss basic information on Hearing... read more
Federal Register: Device Improvements for Pediatric X-Ray Imaging; Public Meeting; Request for Comments
FDA is announcing the following public meeting on the draft guidance. This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and interventional fluoroscopy devices. FDA... read more
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability
This draft guidance document outlines FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use in pediatric populations.... read more
FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients
The FDA is alerting people with MS to the risks of serious injuries and death associated with procedures to treat chronic cerebrospinal venous insufficiency (CCSVI). Furthermore, the benefits of these... read more
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Biologic Product Shortages
Complete List of Currently Approved NDA and ANDA Application Submissions
Information updated through April 30, 2012
Complete List of Currently Approved Premarket Approvals (PMAs)
Information updated through April 30, 2012
Complete List of Substantially Equivalent 510(k) Device Applications
Information updated through April 30, 2012
