Remove Cosmetics Remove FDA Approval Remove Licensing Remove Pharma Companies
article thumbnail

Q&A: The IND Journey Phase I – Navigating Success

Advarra

The sponsor-initiated IND is conducted by a pharma company seeking commercial approval. Q: When you want to do a study of an FDA-approved drug under an investigational indication, is an IND still required or can you seek an exemption? Then you can submit an application for approval.