| Title and Format |
Type |
Issue Date |
| Analytical Procedures and Methods Validation.(PDF - 91 KB) |
Draft |
8/2000 |
| BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation 2/2001 |
Final |
Withdrawn as per FR notice June 1, 2006 |
| Botanical Drug Products (PDF - 437 KB) |
Final |
6/2004 |
| Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (PDF - 33 KB) |
Final |
7/1997 |
| Changes to an Approved NDA or ANDA (PDF - 108 KB) |
Final |
4/2004 |
| Changes to an Approved NDA or ANDA: Questions and Answers (PDF - 35 KB) |
Final |
1/2001 |
| Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (PDF - 18 KB) |
Final |
11/19/2004 |
| Comparability Protocols -- Chemistry, Manufacturing, and Controls Information (PDF - 240 KB) |
Draft |
2/2003 |
| Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164 KB)
|
Final |
5/1999
5/2002 |
| Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products |
Final |
4/1996 |
| Development of New Stereoisomeric Drugs |
Final |
5/1/1992 |
Drug Master Files
Current DMF Information (e.g. lists, addresses, guidances, etc.) |
Final |
9/1/1989 |
| Drug Master Files for Bulk Antibiotic Drug Substances (PDF - 23 KB) |
Final |
11/1999 |
| Drug Product: Chemistry, Manufacturing, and Controls Information 1/2003 |
Draft |
Withdrawn as per FR notice June 1, 2006 |
| Drug Substance: Chemistry, Manufacturing, and Controls Information 1/2004 |
Draft |
Withdrawn as per FR notice June 1, 2006 |
| Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88 KB) |
Draft |
9/11/2003 |
| Environmental Assessment of Human Drug and Biologics Applications (PDF - 188 KB) |
Final |
7/1998 |
| Format and Content of the Chemistry, Manufacturing and Controls Section of an Application* 2/1987 |
Final |
Withdrawn as per FR notice June 1, 2006 |
| Format and Content for the CMC Section of an Annual Report (PDF - 29 KB) |
Final |
9/1/1994 |
| Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 79 KB) |
Draft |
7/13/2009 |
| INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (PDF - 193 KB) |
Final |
5/20/2003 |
| IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF - 30 KB) |
Final |
5/2001 |
| Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF - 26 KB) |
Draft |
7/24/1999 |
| Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.(PDF - 45 KB) |
Draft |
7/2002 |
| Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 29 KB) |
Final |
3/2001 |
| Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products (PDF - 361 KB) |
Draft |
11/13/1998 |
| Nasal Spray and Inhalation Solution, Suspension, and Drug Products (PDF - 116 KB) |
Final |
7/2002 |
| NDAs: Impurities in Drug Substances (PDF - 11 KB) |
Final |
2/2000 |
| Orally Disintegrating Tablets (PDF - 52 KB) |
Final |
12/17/2008 |
| PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites (PDF - 76 KB) |
Final |
4/28/1998 |
| Residual Solvents in Drug Products Marketed in the United States (PDF - 58 KB) |
Draft |
8/6/2008 |
Reviewer Guidance, Validation of Chromatographic Methods (PDF - 703 KB)
(revised to include graphics, 5/14/2007) |
Final |
11/1994 |
| The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE)(PDF - 790 KB) |
Final |
12/20/2000 |
| Stability Testing of Drug Substances and Drug Products 6/5/1998 |
Draft |
Withdrawn as per FR notice June 1, 2006 |
| Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances 11/1994 |
Final |
Withdrawn as per FR notice June 1, 2006 |
| Submitting Documentation for the Manufacturing of and Controls for Drug Products*(PDF - 1.02 MB) |
Final |
2/1987 |
| Submitting Documentation for the Stability of Human Drugs and Biologics* (Issued , Posted 3/2/1998) |
Final |
Withdrawn as per FR notice June 1, 2006 |
| Submitting Samples and Analytical Data for Methods Validation |
Final |
2/1987 |
| Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances (PDF - 94 KB) |
Final |
2/1987 |
| 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 - 60 KB) |
Final |
11/1995 |
| SUPAC-IR Questions and Answers about SUPAC-IR Guidance |
Final |
2/18/1997 |
| SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum (PDF - 117 KB) |
Final |
1/1999 |
| 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 - 215 KB) |
Final |
Issued 10/6/1997 |
| SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum (PDF - 61 KB) |
Draft |
12/1998 |
| 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 - 118 KB) |
Final |
5/1997 |
