RegLink Associates

RegLink Associates Welcomes FDA's First Draft Guidance on Risk Evaluation & Mitigation Submission (REMS)

RegLink Associates' Principal, Ansis Helmanis, welcomes FDA's first draft guidance to help companies better understand what is expected in risk evaluation and mitigation strategy submissions. Obligations to fund and support costly studies can extend beyond the date of exclusivity, giving follow-on competitors an advantage. - April 01, 2010