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Q: Does the FDA have any plans to address labeling for over-the-counter products in terms of their impact on pregnancy, lactation, and reproductive potential?
A: The PLLR does not apply to over-the-counter products. However, the agency is continually reviewing the safety of products used over the counter, including impacts on pregnancy, lactation, and reproductive potential.
Q: How does the FDA plan to assess over time the usefulness of the new labeling for prescribers and patients and make revisions?
A: The draft guidance was issued concurrently with PLLR. Based on the comments received from the public on the draft, as well as learning from the initial revisions of labeling, the guidance will be revised as needed. Guidance statements issued by FDA are regularly reviewed and revised as needed.
Dr. Whyte, a board-certified internist, is the director of Professional Affairs and Stakeholder Engagement at the FDA. Do you have other questions about the PLLR? Send them to obnews@frontlinemedcom.com.
