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Luitpold Petitions FDA for Requirements on Iron Products

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A just-posted citizen petition from Luitpold Pharmaceuticals requests that FDA require that any NDA for injectable iron for treati...

Senate Passes Compounding/Track and Trace Bill

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The U.S. Senate passes and sends on to the President legislation on drug compounding safety which included track and trace drug su...

Comments Sought on Special Protocol Assessment Info

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Federal Register Notice: FDA seeks comments on information collection in the guidance on special protocol assessment.

FDA Revises Draft Guidance on Drug Name Placement in Ads

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FDA revises a draft guidance to clarify requirements for product name placement, size, prominence, and frequency in promotional la...

FDA Rejects Ventripoint 510(k) for Hypertension Device

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FDA denies clearance of a Ventripoint Diagnostics 510(k) for its Ventripoint Medical Systems use in pulmonary aterial hypertension...

Woodcock Slashes ANDA Sponsor Communications

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CDER director Janet Woodcock tells a congressional hearing that the Office of Generic Drugs has shut down most communications with...

Hearing on Eyewash Product Rescheduled

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Federal Register Notice: FDA reschedules a public hearing on OTC emergency use eyewash products.

Scleral Plug into Class 2

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Federal Register Final rule: FDA classifies the scleral plug into Class 2 with special controls and is exempting the scleral plugs...

Panel Backs Vanda Drug for Blind Disorder

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An FDA advisory committee unanimously recommends approval for a Vanda Pharmaceuticals NDA for Hetlioz (tasimelteon), indicated for...

FDA Clears Lumenis Array LaserLink Pattern Scanning

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FDA clears a Lumenis 510(k) for its Array LaserLink pattern scanning device for multi-spot laser photocoagulation.