FDA outlines its intention to overhaul the early-stage clinical development process through a planned Expedited IND Pilot, arguing that the changes are needed to prevent drug development from shifting overseas and to accelerate first-in-human clinical trials in the U.S.
Two senior U.S. senators seek answers from FDA about its plans to address ongoing shortages of several critical chemotherapy drugs.
FDA outlines its intention to overhaul the early-stage clinical development process through a planned Expedited IND Pilot, arguing that the changes are needed to prevent drug development from shifting overseas and to accelerate first-in-human clinical trials in the U.S.
Two senior U.S. senators seek answers from FDA about its plans to address ongoing shortages of several critical chemotherapy drugs.
An FDA inspection cites multiple manufacturing and quality system deficiencies at a Zydus Lifesciences Limited sterile manufacturing facility in Ahmedabad, Gujarat, India.
FDA seeks information from a variety of regulatory partners that will help it establish and implement a Quantitative Medicine Innovation Network.
