FDA发布PEPFAR下已批准抗逆转录病毒药物固定复方及单方版本行业指南草案
Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under PEPFAR
FDA宣布公开一份行业指南草案，就PEPFAR采购、用于治疗或预防HIV-1感染的单方及固定复方抗逆转录病毒产品提出申报建议。该草案适用于各组成成分已获FDA批准、且该具体产品或复方已有充分安全有效性证据的版本，Docket编号为FDA-2004-D-0301，文件标注为草案、不用于实施，建议不具约束力。
GUIDANCE DOCUMENT
Draft
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2004-D-0301
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under PEPFAR.” This draft guidance provides recommendations for applications for single-entity antiretroviral (ARV) and ARV fixed-combination (FC) drug products for the treatment or prevention of human immunodeficiency virus-one (HIV-1) infection that are intended for procurement under the President’s Emergency Plan for AIDS Relief (PEPFAR). Specifically, this draft guidance addresses versions of ARV drug products for which the individual ARV drug product components are already FDA-approved and for which substantial evidence of safety and efficacy of the specific drug product or combination drug product already exists. When finalized, this draft guidance will replace the previous final guidance for industry entitled “Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV” issued in October 2006.
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-2004-D-0301.
来源：FDA Pharmaceutical Quality Documents · fda.gov