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Article: FDA-SEC partnership raises questions about disclosure of development and trial reports.(Drug development)
- Article from:
- Validation Times
- Article date:
- April 1, 2004
- Author:
CopyrightCOPYRIGHT 2004 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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WASHINGTON -- FDA's efforts to have drug and biologics makers disclose their "development reports" as part of the agency's drug quality initiative could present some exposure industry had not realized due to the agency's new working agreement with the Securities and Exchange Commission (SEC).
Addressing the Food and Drug Law Institute's (FDLI) 47th Annual Conference here April 15, private industry and SEC attorneys agreed that should a company's development report be disclosed, it could have an impact on stock price and thus pose enforcement actions from two agencies.
FDA and SEC solidified their relationship February 2004 and laid out specific areas ...