Business · 17/01/2006Updated: 10/17/2026 · 1 min read

FDA Publishes Companion Proposed Rule for Investigational New Drugs

The Food and Drug Administration (FDA) is publishing a companion proposed rule to amend its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most Phase 1 investigational drugs from regulatory requirements, allowing for oversight of production under the agency's general statutory authority.