CDER SBIA Chronicles
Drugs in Pregnancy and Lactation: Improved Benefit-Risk Information
The topic of this month’s issue of the FDA/CDER Small Business Chronicles is titled “Drugs in Pregnancy and Lactation: Improved Benefit-Risk Information” and discusses the Pregnancy and Lactation Labeling Rule (PLLR). This rule sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. FDA has posted quite a bit on this topic, but we hope that this two-page summary will help you obtain a quick overview of the requirements along with where to find in-depth information and guidance.
The purpose of this newsletter, the FDA/CDER SBIA Chronicles, is to provide industry with useful information to assist in all aspects of drug marketing and regulation. As always, we would appreciate your input regarding topics that you would like us to write about. If you have topics of interest, please email us atCDERSBIA@fda.hhs.gov.
Our previous newsletters are archived on our webpage at: http://www.fda.gov/
The CDER Small Business and Industry Assistance Team
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.
- Email: CDERSBIA@fda.hhs.gov
- Phone: 1-866-405-5367
- Phone: (301) 796-6707
- Website: http://www.fda.gov/cdersbia
Please take our CDER Small Business survey: https://www.surveymonkey.com/