FDA proposes controversial release of complete response letters

After a long-simmering controversy over regulatory transparency, an FDA task force has proposed releasing its complete response letters to drug developers as part of a wide-ranging plan to let the sun shine in on safety issues, plant inspections and the agency's specific reasons for rejecting a new drug application. BIO has yet to respond to the set of 21 proposals assembled by an FDA task force headed by FDA Principal Deputy Commissioner Joshua Sharfstein. Despite some deep-seated reluctance...