Woodcock Wants Rapid Regulatory Policy Development
Executive Summary
CDER Director says US FDA needs to develop statistical and other guidances faster to keep up with the pace of science and drug development.
You may also be interested in...
Disease-Specific Drug Development Guidances Coming From US FDA In 2018
Alzheimer's disease, amyotrophic lateral sclerosis, migraine, and opioid dependence are among conditions that will get drug development guides from FDA; other guidances will address ANDA bioequivalence studies, shared REMS, and continuous manufacturing.
Disease-Specific Drug Development Guidances Coming From US FDA In 2018
Alzheimer's disease, amyotrophic lateral sclerosis, migraine, and opioid dependence are among conditions that will get drug development guides from FDA; other guidances will address ANDA bioequivalence studies, shared REMS, and continuous manufacturing.
Alzheimer's Guidance Coming From US FDA, Part Of Broader OND Reform
'Believe it or not, we don't have as many disease-specific guidances as you would suspect on the new drug side,' Commissioner Gottlieb says.