miércoles, 3 de diciembre de 2014

CDER SBIA Update: Pregnancy and Lactation Labeling Final Rule

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

Pregnancy and Lactation Labeling Final Rule
The FDA has published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR or final rule).
The PLLR final rule sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.
The final rule replaces the current product letter categories – A, B, C, D and X – used to classify the risks of using prescription drugs during pregnancy with three detailed subsections that describe risks within the real-world context of caring for pregnant women who may need medication. The PLLR also requires the label to be updated when information becomes outdated.
The FDA is also issuing a draft guidance for industry to help drug and biological product manufacturers comply with the new labeling content and format requirements. The draft guidance provides a detailed description of how the labeling is to be formatted subsection-by-subsection, noting the type of information that should be included under each heading.  Although comments on a guidance can be submitted at any time, 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submitted within 60 days of publication to ensure that they are considered when the FDA begins work on finalizing the draft guidance. 
Additional information is located at: PLLR Final Rule

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
Please take our CDER Small Business survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation

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