FDA Fetal Pharmacology and Therapeutics Workshop

FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation are sponsoring a two-day virtual public workshop on “Fetal Pharmacology and Therapeutics” on 10/21-10/22. An announcement says the workshop will discuss the current state of fetal pharmacology and therapeutics and how it pertains to pediatric drug development.

The announcement lists these workshop objectives: 

•          review general regulatory and ethical considerations for fetal pharmacology and therapeutics;
•          describe methods to assess clinical and nonclinical safety and efficacy assessments to support clinical trials of drugs in pregnancy and the fetus;
•          highlight advances and existing knowledge in fetal therapeutics; and
•          discuss key aspects of maternal-fetal modeling and simulation.

The workshop is open to the public and intended for clinicians, academics, drug developers, and regulators. There is no fee and registration is required.