US FDA Final Rule and Draft Guidance for Industry- Pregnancy and Lactation Labeling
The Teratology Society applauds the US Food and Drug Administration's publication today of a Final Rule that sets regulations for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products.
The final rule is part of a broad effort by the agency, which began with the Physician Labeling Rule, to improve the content and format of prescription drug labeling. The rule finalizes many of the provisions in the proposed rule that the FDA issued in May 2008, and will be in effect as of June 30, 2015.
The FDA is also issuing a draft guidance for industry, which provides a detailed description of how the labeling is to be formatted subsection-by-subsection. Any public comments should be submitted within 60 days of publication to ensure that they are considered when the FDA begins work on finalizing the draft guidance.
The Teratology Society was represented on the stakeholder teleconference that FDA held yesterday announcing the release of the new regulations. In Dr. Sandra Kweder's opening remarks she acknowledged the contributions of the Teratology Society, OTIS and others in drafting the rule.
View the full FDA News Release for more details and to submit comments.