FDA Approval Process for Drugs and Medical Devices

Many consumer groups feel that the U.S. Food and Drug Administration (FDA) drug approval process is too easy and, as a result, too many drugs are approved that are later found to be unsafe. On the other hand, a number of industry lobbyists have pushed for a more lenient approval process so that pharmaceutical companies can get new drugs approved more easily and quickly. Consider a null hypothesis that a new, unapproved drug is unsafe and an alternative hypothesis that a new, unapproved drug is s

New Drug Application (NDA): Back to the Basics | LexisNexis Reed Tech

after years of clinical research your company submits a new drug application for a drug evaluated in children with attention deficit hyperactivity disorder adhdi you are surprised to receive 87942