Which US Agency Is Responsible For Testing And Approving New Medications? Developing New Drugs The main consumer watchdog in this system is FDA’s Center for Drug Evaluation and Research (CDER). The center’s best-known job is to evaluate new drugs before they can be sold. Who is responsible for approval of new drugs in India? The
How Does The FDA Decide To Approve A New Drug? The drug sponsor formally asks FDA to approve a drug for marketing in the United States by submitting an NDA. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body
What Are The FDA Requirements For Bringing A Drug To Market? Step 1: Discovery and Development. Step 2: Preclinical Research. Step 3: Clinical Research. Step 4: FDA Drug Review. Step 5: FDA Post-Market Drug Safety Monitoring. How does a new drug come to market? Some companies submit a new drug application (NDA) to introduce a