Drugs

Chemistry, Manufacturing, and Controls (CMC)

Below is a sortable table of Chemistry, Manufacturing and Controls (CMC) Guidances:

Category	Title	Type	Date
Chemistry, Manufacturing, and Controls (CMC)	Analytical Procedures and Methods Validation (PDF - 91KB)	Draft Guidance	08/30/00
Chemistry, Manufacturing, and Controls (CMC)	Assay Development for Immunogenicity Testing of Therapeutic Proteins (PDF - 161KB)	Draft Guidance	12/04/09
Chemistry, Manufacturing, and Controls (CMC)	Botanical Drug Products (PDF - 437KB)	Final Guidance	06/01/04
Chemistry, Manufacturing, and Controls (CMC)	Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (PDF - 33KB)	Final Guidance	07/01/97
Chemistry, Manufacturing, and Controls (CMC); Modernization Act	Changes to an Approved NDA or ANDA (PDF - 173KB)	Final Guidance	04/01/04
Chemistry, Manufacturing, and Controls (CMC)	Changes to an Approved NDA or ANDA: Questions and Answers (PDF - 35KB)	Final Guidance	01/01/01
Chemistry, Manufacturing, and Controls (CMC)	Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (PDF - 24KB)	Final Guidance	11/19/04
Chemistry, Manufacturing, and Controls (CMC)	CMC Postapproval Manufacturing Changes Reportable in Annual Reports (PDF - 78KB)	Draft Guidance	06/24/10
Chemistry, Manufacturing, and Controls (CMC)	Comparability Protocols -- Chemistry, Manufacturing, and Controls Information (PDF - 195KB)	Draft Guidance	02/25/03
Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products	Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products		02/01/08
Chemistry, Manufacturing, and Controls (CMC)	Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB)	Final Guidance	05/01/99
Chemistry, Manufacturing, and Controls (CMC)	Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers (PDF - 34KB)	Final Guidance	05/01/02
Chemistry, Manufacturing, and Controls (CMC)	Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products	Final Guidance	04/01/96
Chemistry, Manufacturing, and Controls (CMC)	Development of New Stereoisomeric Drugs	Final Guidance	05/01/92
	Drug Master Files: Guidelines
Chemistry, Manufacturing and Controls (CMC)	Drug Master Files (DMFs)	Additional Information regarding DMF's
Chemistry, Manufacturing, and Controls (CMC)	Drug Master Files for Bulk Antibiotic Drug Substances (PDF - 23KB)	Final Guidance	11/01/99
Chemistry, Manufacturing, and Controls (CMC)	Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88KB)	Draft Guidance	09/11/02
Chemistry, Manufacturing, and Controls (CMC)	Environmental Assessment of Human Drug and Biologics Applications (PDF - 188KB)	Final Guidance	07/01/98
Chemistry, Manufacturing, and Controls (CMC)	Format and Content for the CMC Section of an Annual Report (PDF - 29KB)	Final Guidance	09/01/94
Chemistry, Manufacturing, and Controls (CMC)	Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 74KB)	Final Guidance	10/11/11
Chemistry, Manufacturing, and Controls (CMC)	INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (PDF - 283KB)	Final Guidance	05/20/03
Chemistry, Manufacturing, and Controls (CMC)	IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF - 30KB)	Final Guidance	05/01/01
	Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF - 26KB)
Chemistry, Manufacturing and Controls (CMC)	Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products (PDF - 60KB)	Draft Guidance	03/01/12
Chemistry, Manufacturing, and Controls (CMC)	Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 146KB)	Draft Guidance	08/21/02
Chemistry, Manufacturing, and Controls (CMC)	Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 29KB)	Final Guidance	03/01/01
Chemistry, Manufacturing, and Controls (CMC)	Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products (PDF - 361KB)	Draft Guidance	11/19/98
Chemistry, Manufacturing, and Controls (CMC)	Nasal Spray and Inhalation Solution, Suspension, and Drug Products (PDF - 285KB)	Final Guidance	07/01/02
Chemistry, Manufacturing, and Controls (CMC)	NDAs: Impurities in Drug Substances (PDF - 11KB)	Final Guidance	02/01/00
Chemistry, Manufacturing, and Controls (CMC)	Orally Disintegrating Tablets (PDF - 52KB)	Final Guidance	12/17/08
Chemistry, Manufacturing, and Controls (CMC)	PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites (PDF - 76KB)	Final Guidance	04/28/98
Chemisty; Manufacturing and Controls (CMC)	Regulatory Classification of Pharmaceutical Co-Crystals (PDF - 97KB)	Draft Guidance	12/01/11
Chemistry, Manufacturing, and Controls (CMC)	Residual Drug in Transdermal and Related Drug Delivery Systems (PDF - 44KB)	Final Guidance	08/16/11
Chemistry, Manufacturing, and Controls (CMC)	Residual Solvents in Drug Products Marketed in the United States (PDF - 52KB)	Final Guidance	11/24/09
Chemistry, Manufacturing, and Controls (CMC)	Reviewer Guidance, Validation of Chromatographic Methods (PDF - 703KB)	Final Guidance	11/01/94
Chemistry, Manufacturing, and Controls (CMC)	Size of Beads in Drug Products Labeled for Sprinkle. (PDF - 148KB)	Final Guidance Note: Corrected a non-substantive error on p. 2 of guidance	05/02/12
Chemistry, Manufacturing, and Controls (CMC)	Submitting Documentation for the Manufacturing of and Controls for Drug Products (PDF - 1MB)	Final Guidance	02/01/87
Chemistry, Manufacturing, and Controls (CMC)	Guidelines for Submitting Samples and Analytical Data for Methods Validation	Final Guidance	02/01/87
Chemistry, Manufacturing, and Controls (CMC)	Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances (PDF - 94KB)	Final Guidance	02/01/87
Chemistry, Manufacturing, and Controls (CMC)	SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (PDF - 60KB)	Final Guidance	11/01/95
Chemistry, Manufacturing, and Controls (CMC)	SUPAC-IR Questions and Answers about SUPAC-IR Guidance	Final Guidance	02/18/97
Chemistry, Manufacturing, and Controls (CMC)	SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum (PDF - 117KB)	Final Guidance	01/01/99
Chemistry, Manufacturing, and Controls (CMC)	SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (PDF - 215KB)	Final Guidance	10/06/97
Chemistry, Manufacturing, and Controls (CMC)	SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum (PDF - 61KB)	Draft Guidance	12/01/98
Chemistry, Manufacturing, and Controls (CMC)	SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (PDF - 118KB)	Final Guidance	05/01/97
Guidance for Industry - The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use	The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use		09/01/97
Chemistry, Manufacturing, and Controls (CMC)	Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation (PDF - 99KB)	Draft Guidance	08/29/11

Drugs

Section Contents Menu

Guidance, Compliance & Regulatory Information

Chemistry, Manufacturing, and Controls (CMC)

Links on this page: