One Week Left for CTIS Mandatory Use Date

GenAI is on the precipice of making regulatory strategists more efficient by alleviating challenges, streamlining regulatory research and submission processes.

New laws leave consumers unprotected against third parties accessing their genetic data.

Agency will be reorganizing field force and compliance functions.

Exploring the implications of FDA’s renewed focus and commitment to expand the use of accelerated approval for gene therapy products.

EU proposal focuses on a subset of underserved rare diseases—exploring the gaps in those conditions for which there is no approved treatment option.

Cleve talks about the future of the industry and how data remains a key focus.