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Comments Sought on Device Recall Authority

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Federal Register Notice: FDA seeks comments on information collection requirements for device recall authority.

Travatan Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Travatan 0.004% was not withdrawn from sale for reasons of safety or effectiveness.

Look at Dietary Supplement Adverse Events: Congressmen

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Two congressmen ask the Government Accountability Office to research and report on dietary supplement adverse event reporting.

Shuren Tells Hearing How to Fix Rising Approval Times

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At a Senate hearing, CDRH director Jeff Shuren provides his perspective on how to reduce rising medical device approval times.

CooperVision Expands Contact Lens Recall

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CooperVision says it is now recalling some lots of its Avaira Sphere contact lenses.

FDA Approves Incytes Jakafi for Myelofibrosis

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FDA approves Incytes Jakafi dosed twice daily to treat myelofibrosis.

FDA Approves Merz Belotero

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FDA approves Merz Aesthetics Belotero dermal filler for correcting moderate to severe nasolabial folds.

Evidence Backs Restrictions on Animal Antibiotics: Researcher

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Tufts University researchers say there is considerable evidence to support greater restrictions on non-therapeutic use of antibiot...

FDA Working on New Media Policy

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An FDA official tells a Union of Concerned Scientists conference that the agency is developing a new media relations policy for ag...

Info on Extra-label Drug Use Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on extra-label drug use in animals.