The price of FDA's clinical trial plan

WASHINGTON - The FDA estimates that its proposed new rules to increase surveillance and reporting of adverse drug effects will cost drug sponsors and manufacturers some $24 million annually, although the rigor of its analysis is hard to evaluate.

In its proposal, published in the Federal Register last week, the agency said it "is proposing to amend the requirements for clinical study design and conduct and the sponsor reporting requirements in the investigational new drug application (IND) regulations. These amendments are intended to provide more complete and accurate information that would enable sponsors, investigators, and FDA to determine serious toxicities of investigational drugs more expeditiously during clinical studies."...