To include your compound in the COVID-19 Resource Center, submit it here.

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

Read the full 622 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury


Article Purchase

This article may not be distributed to non-subscribers