The FDA has released new guidance on postapproval pregnancy safety studies for drugs and biologics, highlighting pregnancy registries, real-world evidence, and postmarketing surveillance expectations for manufacturers.

The FDA 's new guidance on the evaluation of gender-specific data in clinical studies with medical devices highlights the importance of including men and women in a representative way in trial samples. The analysis of gender-differentiated data makes it possible to identify possible variations in the efficacy and safety of medical devices, contributing to a more rigorous and inclusive evaluation.