FDA primer on 'effectiveness'

WASHINGTON - The FDA followed through on one of its "reinventing government" promises last week by publishing a formal statement on demonstrations of product effectiveness in new drug applications (NDAs) and premarket approval applications (PMAs). The statement, which it promised in March to issue (see BioCentury, Apr. 3), also discussed the agency's position on the need for corroborating trials.

However the statement said

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