Question

On 19 March 1987, the FDA issued regulations outlined in 21 CFR 312.21 (Investigational New Drug Application 2014) to support the Investigational New Drug (IND) process which identified the different phases of research involved. These regulations mandate that an IND application must be submitted for:______.

Answer 1

Answer:

approving a new drug for marketing.

Explanation:

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. This organization is responsible for promoting public health through a series of laws that promote oversight of a number of products that are in the US market, as well as control of safety and efficiency testing for new products to reach the market.