---

21 C.F.R. § 314.445   Guidance documents.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart G—Miscellaneous Provisions

Browse Previous

§ 314.445   Guidance documents.

(a) FDA has made available guidance documents under §10.115 of this chapter to help you to comply with certain requirements of this part.

(b) The Center for Drug Evaluation and Research (CDER) maintains a list of guidance documents that apply to CDER's regulations. The list is maintained on the Internet and is published annually in the Federal Register. A request for a copy of the CDER list should be directed to the Office of Training and Communications, Division of Communications Management, Drug Information Branch (HFD–210), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

[65 FR 56480, Sept. 19, 2000]

Browse Previous