Elizabeth Mulkey

Charting A Conditional Approval Pathway For Rare Disease Drugs – A Top Priority For A Revamped FDA?

How To (Finally) Get Your SIUU Out: FDA Issues Final Guidance On Communicating Off-Label Scientific Information

A Look Ahead In Life Sciences: What We Are Tracking In The Fourth Quarter Of 2024 And Beyond

FDA Issues Overdue Draft Guidance On Clinical Trial Diversity Action Plans

Goodwin Releases Update To Its Comprehensive Guide To Biosimilars Litigation And Regulation In The U.S.

A Look Ahead In Life Sciences: What We Are Tracking In Q1 2024 And Beyond

How To Get Your SIUU Out: FDA Provides Long-Awaited Update For Industry On Communicating Off-Label Information

Clinical Trial Diversity Plans And Rare Diseases

Congress Expands Pathway For Drug & Device Manufacturers' Pre-Approval Communication Of Health Care Economic Information To Payors, Formularies, & Similar Entities

Clinical Trial Diversity Planning For Sponsors: What To Know About FDA's Recent Draft Guidance