www.fdanews.com/articles/178290-fda-reduces-follow-up-requirement-for-plantar-fasciitis-study
FDA Reduces Follow-Up Requirement for Plantar Fasciitis Study
September 7, 2016
FDA reduced the follow-up requirement from two years to one year for a Phase IIb study of injectable AmnioFix for the treatment of plantar fasciitis.
The approval of the protocol amendment was based on the injection’s safety profile and a lack of immunogenic response in study patients. Begun by MiMedx in August 2014, the trial involves up to 146 subjects at 20 clinical sites.