FDA 关于原料抗生素原料药 Drug Master Files 的行业指南（1999年11月最终版，Docket No. FDA-1999-D-1314）
Drug Master Files for Bulk Antibiotic Drug Substances
FDA 发布《Drug Master Files for Bulk Antibiotic Drug Substances》行业指南最终版，Docket Number 为 FDA-1999-D-1314，由 CDER 签发。
GUIDANCE DOCUMENT
Drug Master Files for Bulk Antibiotic Drug Substances Guidance for Industry November 1999
Final
- Docket Number:
- FDA-1999-D-1314
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance is intended for those in industry whose approved applications for bulk antibiotic drug substances (i.e., bulk applications) were converted to Type II Drug Master Files (DMFs) when section 507 of the Federal Food, Drug, and Cosmetic Act was repealed as part of the enactment of section 125 of Title I of the Food and Drug Administration Modernization Act on November 21, 1997. This guidance explains the purpose of DMFs, discusses the type of information expected in a Type II DMF, outlines administrative procedures governing review of DMFs, and clarifies your responsibilities as a DMF holder. The information presented in this guidance is also relevant to the submission of new DMFs for bulk antibiotic drug substances.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-1999-D-1314.
来源：FDA Pharmaceutical Quality Documents · fda.gov