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.

Health Canada eliminates reconsideration requests for priority review and NOC/c decisions from April 2026. Key regulatory impacts for drug sponsors explained.

FDA updates SOPP 8212 on breakthrough therapy designation. Key changes in timelines, communication, and lifecycle management for manufacturers.