FDA’s Expansion of IND Regulations Impose Yet Another Major Regulatory Hurdle for Medical Food Companies
On September 10, 2013, FDA published a new guidance document restricting the scope of research permitted for dietary supplements and medical foods without first submitting an Investigational New Drug application (“IND”). The document titled, “Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted […]
