CFR section
21 CFR 312.7(a): Promotion of investigational drugs
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 312.7(a) |
|---|---|
| Section | Promotion of investigational drugs |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media… |
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