Posted by Michael Wonder on 07 Dec 2021
Product approval and public health at the US Food and Drug Administration
6 December 2021 - Since the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act, drug approval in the United States has been based on an assessment of the benefits and risks of a medication’s use.
In assessing a product approval application, the Food and Drug Administration (FDA) is required to consider whether the product is safe and effective “under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.”
