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Article: FDA warning letter clarified by biotech firm.
- Article from:
- Drug Week
- Article date:
- June 25, 2004
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2004 JUN 25 - (NewsRx.com & NewsRx.net) -- Celsion Corp. (CLN) announced that it has received a warning letter from the U.S. Food and Drug Administration (FDA) regarding the phase I and phase II clinical trials of its Prolieve Thermodilatation system for the treatment of benign prostatic hyperplasia, or BPH.
The FDA granted premarketing approval (PMA) to Celsion for the Prolieve system earlier this year, and the system currently is being marketed under a distribution agreement between Celsion and Boston Scientific Corporation.
The warning letter reflects matters that arose during the course of a pre-approval inspection conducted by the FDA's Baltimore ...