FDA工业指南目录

星云道

整理了一份和常规制药企业相关度比较高的FDA工业指南目录，供大家参考，源文件全部可以上FDA官网免费下载，就不提供了哈。

编号	文件名称	发行日期	状态
FDA-1997-D-0029	General Principles of Software  Validation: Guidance for Industry and FDA Staff	01/11/2002	Final
FDA-1997-D-0145	Container Closure Systems for  Packaging Human Drugs and Biologics: Guidance for Industry	07/07/1999	Final
FDA-1997-D-0489	Expiration Dating and Stability  Testing of Solid Oral Dosage Form Drugs Containing Iron: Guidance for Industry	07/09/1997	Final
FDA-1998-D-0019	Investigating  Out-of-Specification Test Results for Pharmaceutical Production: Guidance for  Industry	10/12/2006	Final
FDA-1998-D-0278	Environmental Assessment of  Human Drug and Biologics Applications: Guidance for Industry	07/27/1998	Final
FDA-1999-D-0060	Nasal Spray and Inhalation  Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and  Controls Documentation: Guidance for Industry	07/05/2002	Final
FDA-1999-D-0128	Cooperative Manufacturing  Arrangements for Licensed Biologics: Guidance for Industry	11/28/2008	Final
FDA-1999-D-1314	Drug Master Files for Bulk  Antibiotic Drug Substances: Guidance for Industry	11/29/1999	Final
FDA-2003-D-0143	Part 11, Electronic Records;  Electronic Signatures - Scope and Application: Guidance for Industry	09/05/2003	Final
FDA-2003-D-0145	Sterile Drug Products Produced by  Aseptic Processing — Current Good Manufacturing Practice: Guidance for  Industry	10/04/2004	Final
FDA-2003-D-0431	Current Good Manufacturing Practice  for Medical Gases: Draft Guidance for Industry	06/29/2017	Draft
FDA-2004-D-0121	Premarketing Risk Assessment: Guidance  for Industry	03/29/2005	Final
FDA-2007-D-0365	Orally Disintegrating Tablets: Guidance  for Industry	12/16/2008	Final
FDA-2007-D-0420	The Use of Mechanical  Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing  Practice (CGMP): Guidance for Industry	01/27/2010	Final
FDA-2008-D-0060	Container and Closure System Integrity  Testing in Lieu of Sterility Testing as a Component of the Stability Protocol  for Sterile Products: Guidance for Industry	02/25/2008	Final
FDA-2008-D-0413	Residual Solvents in Drug  Products Marketed in the United States: Guidance for Industry	11/25/2009	Final
FDA-2008-D-0559	Process Validation: General  Principles and Practices: Guidance for Industry	01/25/2011	Final
FDA-2009-D-0179	Technical Considerations for  Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological  Products: Guidance for Industry and FDA Staff	06/07/2013	Final
FDA-2009-D-0212	Incorporation of Physical-Chemical  Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting:  Guidance for Industry	10/11/2011	Final
FDA-2010-D-0530	Considering Whether an  FDA-Regulated Product Involves the Application of Nanotechnology: Guidance  for Industry	06/23/2014	Final
FDA-2011-D-0104	Non-Penicillin Beta-Lactam  Drugs: A CGMP Framework for Preventing Cross-Contamination: Guidance for  Industry	04/17/2013	Final
FDA-2012-D-0083	Heparin for Drug and Medical  Device Use: Monitoring Crude Heparin for Quality: Guidance for Industry	06/25/2013	Final
FDA-2012-D-0881	Self-Identification of Generic  Drug Facilities, Sites, and Organizations; Guidance for Industry	09/23/2016	Final
FDA-2013-D-0362	Glass Syringes for Delivering  Drug and Biological Products: Technical Information to Supplement International  Organization for Standardization (ISO) Standard 11040-4: Draft Guidance for  Industry and FDA Staff	03/31/2013	Draft
FDA-2013-D-0558	Contract Manufacturing Arrangements  for Drugs: Quality Agreements Guidance for Industry: Guidance for Industry	11/23/2016	Final
FDA-2013-D-0710	Circumstances that Constitute  Delaying, Denying, Limiting, or Refusing a Drug Inspection: Guidance for  Industry	10/22/2014	Final
FDA-2013-D-1020	Bioanalytical Method Validation  Guidance for Industry	05/22/2018	Final
FDA-2013-D-1543	Nonproprietary Naming of Biological  Products: Update Guidance for Industry	03/08/2019	Draft
FDA-2014-D-0779	Current Good Manufacturing  Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under  Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for  Industry	01/22/2020	Draft
FDA-2014-D-1288	Electronic Submission of Lot  Distribution Reports: Guidance for Industry	03/23/2015	Final
FDA-2014-D-1524	Repackaging of Certain Human  Drug Products by Pharmacies and Outsourcing Facilities: Guidance for Industry	01/13/2017	Final
FDA-2014-D-1747	Risk Evaluation and Mitigation Strategies:  Modifications and Revisions Guidance for Industry	07/09/2019	Final
FDA-2015-D-2537	Submission of Quality Metrics  Data Guidance for Industry	11/25/2016	Draft
FDA-2015-D-3438	Selection of the Appropriate  Package Type Terms and Recommendations for Labeling Injectable Medical  Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use  Containers for Human Use: Guidance for Industry	10/03/2018	Final
FDA-2015-D-4644	Advancement of Emerging  Technology Applications for Pharmaceutical Innovation and Modernization  Guidance for Industry	09/29/2017	Final
FDA-2015-N-3454	Manufacturing Site Change Supplements:  Content and Submission: Guidance for Industry and Food and Drug  Administration Staff	12/17/2018	Final
FDA-2016-D-0643	Labeling for Biosimilar Products Guidance  for Industry	07/18/2018	Final
FDA-2016-D-0973	Comparability Protocols for  Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information  Guidance for Industry	04/20/2016	Draft
FDA-2016-D-1490	Quality Attribute Considerations  for Chewable Tablets Guidance for Industry	08/21/2018	Final
FDA-2016-D-1692	Elemental Impurities in Drug  Products Guidance for Industry	08/08/2018	Final
FDA-2016-D-4317	Compounding and Repackaging of  Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry	09/26/2018	Final
FDA-2016-D-4318	Compounding and Repackaging of  Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal  Facilities Guidance for Industry	09/26/2018	Final
FDA-2017-D-0829	Expiration Dating of Unit-Dose  Repackaged Solid Oral Dosage Form Drug Products: Guidance for Industry	07/29/2020	Final
FDA-2017-D-2163	Child-Resistant Packaging  Statements in Drug Product Labeling Guidance for Industry	08/13/2019	Final
FDA-2017-D-6231	Use of a Drug Master File for Shared  System REMS Submissions Guidance for Industry	11/09/2017	Draft
FDA-2018-D-0688	Standardization of Data and  Documentation Practices for Product Tracing Guidance for Industry	03/02/2018	Draft
FDA-2018-D-1339	Multiple Function Device  Products: Policy and Considerations: Guidance for Industry and Food and Drug  Administration	07/29/2020	Final
FDA-2018-D-1434	Waivers, Exceptions, and  Exemptions from the Requirements of Section 582 of the Federal Food, Drug,  and Cosmetic Act Guidance for Industry	05/09/2018	Draft
FDA-2018-D-1895	Indications and Usage Section of  Labeling for Human Prescription Drug and Biological Products — Content and  Format Guidance for Industry	07/06/2018	Draft
FDA-2018-D-2074	Initiation of Voluntary Recalls  Under 21 CFR Part 7, Subpart C: Draft Guidance for Industry and FDA Staff	04/24/2019	Draft
FDA-2018-D-2614	Dissolution Testing and  Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug  Products Containing High Solubility Drug Substances Guidance for Industry	08/09/2018	Final
FDA-2018-D-3151	Postapproval Changes to Drug  Substances Guidance for Industry	09/11/2018	Final
FDA-2019-D-1768	Harmonizing Compendial Standards  With Drug Application Approval Using the USP Pending Monograph Process  Guidance for Industry	07/10/2019	Draft
FDA-2019-D-1917	Drug Abuse and Dependence Section  of Labeling for Human Prescription Drug and Biological Products — Content and  Format  Guidance for Industry	07/01/2019	Draft
FDA-2019-D-2153	Establishing Effectiveness and Safety  for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for  Industry	07/12/2019	Draft
FDA-2019-D-2397	Using the Inactive Ingredient  Database Guidance for Industry	07/11/2019	Draft
FDA-2019-D-3953	Providing Regulatory Submissions  in Electronic Format: IND Safety Reports: Guidance for Industry	10/30/2019	Draft
FDA-2019-D-3989	Drug Master Files Guidance for  Industry	11/15/2019	Draft
FDA-2019-D-5270	Biosimilars and Interchangeable  Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the  Reference Product Has Been Licensed Guidance for Industry: Draft Guidance for  Industry	02/07/2020	Draft
FDA-2020-D-0276	Compliance Policy for the  Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR  320.38(c) : Guidance for Industry	08/18/2020	Final
FDA-2020-D-0420	Providing Regulatory Submissions  in Alternate Electronic Format Guidance for Industry: Draft Guidance for  Industry	03/11/2020	Draft
FDA-2020-D-0567	Restricted Delivery Systems: Flow  Restrictors for Oral Liquid Drug Products Guidance for Industry	03/17/2020	Draft
FDA-2020-D-1057	Notifying FDA of a Permanent  Discontinuance or Interruption in Manufacturing Under Section 506C of the  FD&C Act Guidance for Industry: Guidance for Industry	03/27/2020	Final
FDA-2020-D-1530	Control of Nitrosamine  Impurities in Human Drugs: Guidance for Industry	09/02/2020	Final
None found	Container Closure Systems for  Packaging Human Drugs and Biologics -- Questions and Answers: Guidance for  Industry	05/01/2002	Final
	Product Recalls, Including  Removals and Corrections: Guidance for Industry	03/02/2020	Final
	Sterility Requirement for  Aqueous-Based Drug Products for Oral Inhalation — Small Entity Compliance  Guide: Guidance for Industry	11/07/2001	Final
	Mixing, Diluting, or Repackaging Biological  Products Outside the Scope of an Approved Biologics License Application: Guidance  for Industry	01/18/2018	Final
	Postapproval Changes to Drug  Substances Guidance for Industry: Draft Guidance for Industry	09/01/2018	Draft
	Submission of Documentation in  Applications for Parametric Release of Human and Veterinary Drug Products  Terminally Sterilized by Moist Heat Processes: Guidance for Industry	02/25/2010	Final

syhorchid

谢谢分享

胜利者

谢谢

刘萝莉CC

感谢分享！

scslk0045

谢谢分享！

南瓜控

谢谢分享！

低调zjj

感谢分享，原来这个指南有这么多

常翔宇1

谢谢楼主分享

zackzong

谢谢楼主分享

小金库

谢谢分享。

张思雨

谢谢分享。

cgly1986

谢谢楼主分享，好东西