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Biotech Companies Question FDA Regulation Proposals.(Knight Ridder/Tribune Business News)
Knight Ridder/Tribune Business News, January, 2001 by Rosenberg, Ronald
Jan. 31--Biotechnology companies planning to conduct gene therapy and animal-to-human transplants are questioning new regulations that require them to provide more details about their tests and immediate public notification of side effects.
The proposed regulations from the U.S. Food and Drug Administration are designed to balance patient advocates' call for more public disclosure of controversial gene therapy trials with biotech companies' desire to keeping data confidential for competitive reasons.
The FDA said the new rules will provide public access, through the Internet, to a gene therapy clinical trial's design and safety parameters but without confidential personal information about the participants.
In a gene therapy trial, where...
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