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Multiple Promotion Violations at Busulfex Web Site

[ Price : $8.95]

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

[ Price : $8.95]

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Group Wants Forests Deliresp Withdrawn

[ Price : $8.95]

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

[ Price : $8.95]

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

No Panel Review for LuViva PMA

[ Price : $8.95]

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

Congressman Wants Superior Medicals Pricing Info

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Panel Splits on Vytorin in Kidney Disease Patients

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FDA's Endocrinologic and Metabolic Drugs Advisory Committee splits with its vote to recommend an expanded indication for Vytorin w...

Autor: In Global Economy, FDA Must Abandon Go It Alone

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Deputy commissioner for global regulatory operations and policy Deborah Autor asserts that globalization requires FDA to abandon i...

Make Medical Ghost Writing Illegal: Professors

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Two University of Toronto professors say RICO provisions should be used to punish those who fraudulently sign their names as autho...