FDA Announces Workshop on Osteoporosis Drug Development
Date: September 24, 2015
The U.S. Food and Drug Administration (FDA) has announced that it will hold a Workshop on “Osteoporosis Drug Development: Moving Forward,” to be held on November 4, 2015, 8 a.m. - 5 p.m. in Silver Spring, MD, USA. The workshop will include three sessions: 1) Indication language and target populations for treatment and prevention of osteoporosis 2) Phase 3 clinical trial design issues 3) Surrogate endpoints for fracture and the requirements for validation of a surrogate endpoint. There will also be a public hearing for individuals to present data, information or views. The deadline to notify FDA if one wishes to testify is October 21, 2015. More information about this meeting is available here.