New Pregnancy Drug Labeling Rules Take Effect (white paper)

New pregnancy labeling rules for prescription drugs took effect, June 30, 2015, marking the demise of the pregnancy categories (A, B, C, D, X), in use since 1979. The new rule ushers in what is expected to be an unprecedented era of inclusion regarding descriptive risk and benefit information. According to FDA, “a narrative structure for pregnancy labeling, rather than a category system, is best able to capture and convey the potential risks of drug exposure based on animal or human data, or both.” This regulatory consultant’s paper will provide historical background on pregnancy labeling, an overview of the new regulatory requirements, and a resource for reformatting and rewriting pregnancy labeling in compliance with the new regulations. Download Now