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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.

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