Investigational New Drug Applications

• Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs

Chemistry

• BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation [HTML] or [PDF]  (Issued 2/2001, Posted 2/16/2001) 
• Botanical Drug Products [HTML] or [PDF] or [Word] (Issued 6/2004, Posted 6/9/2004)
• Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Issued 7/1997, Posted 7/28/1997)
• Changes to an Approved NDA or ANDA [Word] or [PDF] (Issued 4/2004, Posted 4/7/2004)
• Changes to an Approved NDA or ANDA: Questions and Answers [HTML] or [PDF] (Issued 1/2001, Posted 1/22/2001)
• Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes [HTML] or [PDF] or [Word]. (Issued 11/19/2004, Posted 11/19/2004)
• Container Closure Systems for Packaging Human Drugs and Biologics [HTML] or [PDF] (Issued 5/1999, Posted 7/6/1999)
  • Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers [PDF] (Issued 5/2002, Posted 5/10/2002)
• Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products
• Development of New Stereoisomeric Drugs (5/1/1992) (Post Date: 1/3/1996)
• Drug Master Files (9/1/1989)
        Current DMF Information (e.g. lists, addresses, guidances, etc.) 
• Drug Master Files for Bulk Antibiotic Drug Substances [PDF] or [Word] (Issued 11/1999, Posted 11/26/1999)
• Environmental Assessment of Human Drug and Biologics Applications (Issued 7/1998, Posted 7/24/98)
• Format and Content of the Chemistry, Manufacturing and Controls Section of an Application* (Issued 2/1987, Posted 3/2/1998)
• Format and Content for the CMC Section of an Annual Report (9/1/1994)
• INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information [Word] or [PDF] (Posted 5/20/2003)
• IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information [HTML] or [PDF] (Issued 5/2001, Posted 6/4/2001)
• Monoclonal Antibodies Used as Reagents in Drug Manufacturing [HTML] or [PDF] (Issued 3/2001, Posted 3/28/2001)
• Nasal Spray and Inhalation Solution, Suspension, and Drug Products [HTML] or [PDF] (Issued 7/2002, Posted 7/3/2002)
• NDAs: Impurities in Drug Substances [HTML] or [PDF] (Issued 2/2000, Posted 2/24/2000)
• PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites (Issued 4/28/1998, Posted 4/28/1998)

• The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) (12/20/2000)

• 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
• SUPAC-IR Questions and Answers about SUPAC-IR Guidance (2/18/1997)
• SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum (Issued 1/1999, Posted 2/25/1999)
• 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 (Issued 10/6/1997, Posted 10/6/1997)
• 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 (Issued 5/1997; Posted 6/16/1997)
• Reviewer Guidance, Validation of Chromatographic Methods
• Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
• Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances
• Submitting Documentation for the Manufacturing of and Controls for Drug Products* [HTML] or [PDF] (Issued 2/1987, Posted 3/2/1998)
• Submitting Documentation for the Stability of Human Drugs and Biologics* (Issued 2/1987, Posted 3/2/1998)
• Submitting Samples and Analytical Data for Methods Validation
• Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances

Chemistry (Draft)

• Analytical Procedures and Methods Validation. Optional format: PDF. (Issued 8/2000, Posted 8/30/2000)
• Comparability Protocols -- Chemistry, Manufacturing, and Controls Information [Word] or [Acrobat] (Issued 2/2003, Posted 2/20/2003)
• Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (Posted 9/11/2003)
• Drug Product: Chemistry, Manufacturing, and Controls Information  (Issued 1/2003, Posted 1/28/2003)
• Drug Substance: Chemistry, Manufacturing, and Controls Information [Word] or [PDF] (Issued 1/2004, Posted 1/6/2004)
• Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations [HTML] or [PDF]  (7/24/1999) 
• Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products [HTML] or [PDF] or (Issued 11/13/1998, Posted 11/19/1998, HTML Posted 9/27/1999)
• Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.   (Issued 7/2002, Posted 8/20/2002)
• Stability Testing of Drug Substances and Drug Products (Issued 6/5/1998, Posted 6/8/1998)
• SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum (Issued 12/1998, Posted 1/5/1999)