Author Question: The U.S. Food and Drug Administration approval is required for: 1. Medical devices, including ... (Read 23 times)

berenicecastro · **on:** Jul 24, 2018

The U.S. Food and Drug Administration approval is required for:

1. Medical devices, including artificial joints
2. Over-the-counter vitamins
3. Herbal products, such as St John's wort
4. Dietary supplements, such as Ensure

Question 2

Under new U.S. Food and Drug Administration labeling, Pregnancy Categories will be:

1. Strengthened with a new coding such as C+ or C- to discern when a drug is more or less toxic to the fetus
2. Changed to incorporate a pregnancy risk summary and clinical considerations on the drug label
3. Eliminated, and replaced with a link to the National Library of Medicine TOXNET Web site for in-depth information regarding pregnancy concerns
4. Clarified to include information such as safe dosages in each trimester of pregnancy