Expanding Indications Under Open INDs-Regulatory and Product Development

Date posted 11 January 2021

Event date 29 January 2021

Via Ground Zero Pharmaceuticals

One key to maximizing the value of your drug/biologic IP and the expense, resources and time expended in beginning medical product development and opening an Investigational New Drug (IND) program under FDA purview is to expand the potential indications for treatment of the construct/product. This can be done by placing new clinical trial protocols under an open IND, or cloning the IND in other FDA Reviewing Divisions or Offices with new protocols. This webinar will discuss various options and requirements for these and other similar initiatives and discuss the advantages of various regulatory and product development pathways to expansion of your development programs. Case studies will be presented and discussed and ample time will be provided for Q & A.

Date: Fri, January 29, 2021
Time: 10:00 AM – 12:00 PM AEDT
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