CFR section
21 CFR 312.8(a)(3): Charging for investigational drugs under an IND
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 312.8(a)(3) |
|---|---|
| Section | Charging for investigational drugs under an IND |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (3) A sponsor must obtain prior written authorization from FDA to charge for an investigational drug. |
At a glance
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.