Risk Communication Panel to Discuss Pregnancy/Lactation Labeling

Federal Register notice: FDA has announced a 3/5-6 Risk Communication Advisory Committee meeting to discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule. The rule was implemented 6/2015 and required changes to labeling to better communicate clinically relevant information to healthcare providers on risks associated with medication exposure during pregnancy and lactation. The agency seeks input and recommendations on: (1) how information in revised labeling is being perceived and used by healthcare providers and other stakeholders, (2) factors that are critical to healthcare providers’ data interpretation and counseling of pregnant women on a drug’s risks and benefits, and (3) how to convey risk information to healthcare providers to accurately and adequately inform risk-benefit considerations. To view the notice, click here.