The physician who uses a new drug that has not been "approved" for a specific indication or a specific age group frequently finds himself in a quandary. The physician using an "old" and time-honored drug usually neither consults the package insert nor searches for U.S. Food and Drug Administration approval. This statement was written to clarify the legal and informational status of the package insert and the role of the FDA in "approving" or "not approving" drugs for specific indications or specific age groups.
FDA and Federal Law
Federal law requires that, before a new drug can be marketed in interstate commerce, it must be demonstrated safe and effective for its intended uses on the basis of substantial evidence submitted to the FDA.
- Copyright © 1978 by the American Academy of Pediatrics