Monday, August 7, 1995
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 nothing new and was couched in broad generalities that leave to the agency's discretion the definition of "strong" clinical data and the decision on whether one or two trials are required for approval.