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12 Years Later, Corrupted CDRH Practices Continue

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Roland Jankelson, former CEO of MyoTronics Inc., reviews the UTMD and TMJI disputes with CDRH in light of his own companys similar...

Mindset Marketing Solutions Launched

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Two drug industry veterans open Mindset Marketing Solutions to project how many people in a neighborhood are likely to have a spec...

Pauley Sues Times Over Lilly-sponsored Supplement

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Newscaster Jane Pauley sues a newspaper and advertising supplement publisher over an interview with her that appeared in a drug co...

Draft Guidance on Absorbable Hemostatic Devices

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CDRH posts a draft guidance that was developed as a special control guidance to support the proposed reclassification of absorbabl...

Guidance on Blue Bird Feed Labels

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Federal Register Notice: FDA releases a draft guidance on blue bird medicated feed labels.

FDA OKs ArteFill Anti-wrinkle Implant

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FDA approves an Artes Medical PMA for its ArteFill non-resorbable aesthetic injectable implant indicated for correcting facial wri...

FDA OKs New Kadian Dosage Strength

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FDA approves an Alpharma Inc. supplemental NDA for Kadian (morphine sulfate) 80mg capsules, indicated for treating pain.

Vermont Judges Reject FDA Drug Label Preemption

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The Vermont Supreme Court rules that FDA drug labeling requirements do not preempt state law because they establish only a floor, ...

With FDA, Has Schering-Plough Found a Magic Bullet?

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Consulting editor John Scharmann reviews Schering-Ploughs continuing success with new NDA approvals while not reaching full GMP co...

FDA Extends Review on Genta Leukemia NDA

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FDA extends by 90 days its review of Gentas NDA for Genasense, indicated for administration with chemotherapy for patients with re...