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FDA Seeks Input on Clinical Trial Rules

WASHINGTON (CN) - The Food and Drug Administration will hold public hearings to gather input on updating rules for clinical trials of FDA-regulated products.

The FDA's stated objectives are "ensuring human subject protection and the quality and integrity of data supporting regulatory decision-making, without being unnecessarily burdensome or unduly impeding implementation of innovative approaches."

At least six regulations or guidance documents have been issued on clinical trial conduct.

The FDA asks the public to register to attend the hearing by April 2, and submitt comments by May 31.

Click the document icon for this regulation and others.

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