BIO Submits Comments on Draft Pregnancy and Lactation Labeling Guidance
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The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products.</p>
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products.
BIO thanks the Agency for their work on developing the final rule for Content and Format of labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling (“PLLR” or “final rule”) and this Draft Guidance. BIO would like to note that the elimination of the pregnancy categories is a major paradigm shift for the healthcare community. FDA’s final rule discusses the development of educational materials for FDA staff, health care providers, and patients. BIO wholeheartedly agrees that outreach efforts by FDA are essential in ensuring that providers are aware of the new requirements for labeling and are able to navigate the information without relying on the pregnancy categories. We also greatly appreciate FDA’s efforts on this matter, as these materials will inform stakeholders on the changes in labeling regulations and how they will have a positive impact on labeling regarding the use of drugs and biologics during pregnancy and lactation.
