The recently finalized Pregnancy Labeling and Lactation Labeling Rule changes the organization of the current Pregnancy and Nursing Mothers section of the US package insert of prescription drugs. The labeling changes will require omission of the current letter categories and reformatting of the sections with inclusion of clinically relevant human and animal data. The labeling changes are significant in that they now require written risk summaries of available safety data; as well as clinical prescribing considerations, including background rates of malformations, and the hazards of untreated disease states for successful pregnancy outcome. The rule covers new drug approvals as well as drugs approved from June 2001. This rule goes into effect June 30, 2015. In response to these changes in prescription drug labeling, the HESI Developmental and Reproductive Toxicology (DART) Technical committee is sponsoring a two-day workshop on this topic. Several Teratology Society members are featured in the agenda.
This workshop aims to:
(1) provide a forum to discuss the impact of the PLLR;
(2) train relevant industry professionals on how to write labels according to the new rule;
(3) provide feedback to the US FDA.
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