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TechneLite Panel Omits Risk Info

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion says that a Lantheus TechneLite exhibit board omits important risk information and mak...

Enhanced Safety Surveillance for TNF Blockers

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FDA says enhanced tumor necrosis factor manufacturer surveillance of malignancies in children and young adults will help it better...

FDA OKs Luitpold Generic Elestat

[ Price : $8.95]

FDA approves a PharmaForce/Luitpold Pharmaceuticals ANDA for a generic version of Merck's Elestat.

Multiple Promotion Violations at Busulfex Web Site

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CDERs Office of Prescription Drug Promotion says that an Otsuka Busulfex Web site omits material facts, makes unsubstantiated clai...

Public Workshop on Developing Sedation Products

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Federal Register Notice: CDER plans a public workshop on the clinical development of sedation products in adults and pediatric age...

Group Wants Forests Deliresp Withdrawn

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Physicians for Integrity in Medical Research asks FDA to revoke its approval for Forest Pharmaceuticals Deliresp to treat COPD.

Embattled Mela Sciences Gains MelaFind Approval

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FDA approves embattled Mela Sciences PMA for its non-invasive diagnostic scanner MelaFind for detecting melanoma.

No Panel Review for LuViva PMA

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FDA says it has decided not to submit Guided Therapeutics LuViva cervical scan PMA to an advisory panel.

Congressman Wants Superior Medicals Pricing Info

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Rep. Elijah Cummings reminds Superior Medical Supply it owes him requested information on the firms purchase and sale of paclitaxe...

Former FDA Chief Counsel Tyler Lands at Venable

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Former FDA chief counsel Ralph Tyler joins Venable as a partner.