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Panel Backs Vanda Drug for Blind Disorder

[ Price : $8.95]

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

FDA Clears Lumenis Array LaserLink Pattern Scanning

[ Price : $8.95]

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

Aptalis Petitions FDA to Block Canasa Generics

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Aptalis Pharma files a citizen petition seeking to block approval of generic versions of Canasa (mesalamine) rectal suppositories,...

FDA Approves Valeant Pharma NDA for Luzu

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FDA approves a Valeant Pharmaceuticals NDA for Luzu (luliconazole) Cream, 1% for topical treatment of athletes foot, jock itch and...

FDA to Participate in Device Single Audit Program

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Federal Register Notice: FDA plans participation in the Medical Device Single Audit Program International Coalition Pilot Program.

FDA Approves Implantable Brain Stimulator for Seizures

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FDA approves a Neuropace PMA for the RNS Stimulator, a device intended to help reduce seizure frequency in epilepsy patients who h...

HHS Study Reviews Human Subject Protections at Biobanks

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A new HHS study recommends that the Office for Human Research Protections provide a forum to IRBs and principal investigators for ...

FDA Faults Revonto Web Page

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CDERs Office of Prescription Drug Promotion says that a Web page for US WorldMeds Revonto misleadingly says it is superior to othe...

United Wants Safety Info in Generic Remodulin Label

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United Therapeutics asks FDA not to allow ANDAs for generic Remodulin injection that carve out important safety information.

Internet Unapproved Drug Sellers Threaten Public Health: NABP

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The National Association of Boards of Pharmacy warns of the continuing global public health threat due to Internet sales of unappr...