Resumen de The FDA Revises Pregnancy Risk Information

Diane S. Aschenbrenner

• * The Food and Drug Administration has finalized revisions to the format and content of pregnancy and lactation information in the labeling of prescription drugs and biological products.

  * The pregnancy categories A, B, C, D, and X will be eliminated. In their place will be “Risk Summary” narratives concerning both pregnancy and lactation. There will also be a summary of information on pregnancy testing, contraception, and infertility under a subheading “Females and Males of Reproductive Potential.”