Statement from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs

February 13, 2019 – Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. One of the fundamental elements of overseeing the quality and safety of pharmaceuticals is having a clear understanding of the specific processes and technologies used to manufacture drugs throughout their lifecycle. This starts before a product is even approved and brought to market, with the FDA’s premarket (or preapproval) review of drug application … (leggi tutto)