Title | Organization(s) | Date |
|---|
| 2012 | | |
Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information (PDF - 85.2KB) | CBER | February 2012 |
| | | |
| 2011 | | |
Guidance for Industry: Process Validation: General Principles and Practices (PDF - 194KB)
| CDER/CBER/CVM | January
2011 |
| 2010 | | |
| Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB) | CDER/CVM/CBER | February 2010 |
| | | |
| 2008 | | |
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics (PDF - 91KB)
| CBER/CDER | November 2008 |
| Guidance for Industry: Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 132KB) | CDER/CBER/ORA | July 2008 |
| | | |
| 2007 | | |
| Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms (PDF - 184KB) | CBER | September 2007 |
| | | |
| 2006 | | |
Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF - 443KB)
| CDER/CBER/CVM/ORA | September 2006 |
DRAFT Guidance for Industry: Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF - 253KB)
| | |
| Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF - 110KB) | CDER/CBER/CVM/ORA/CGMP | January 2006 |
| | | |
| 2005 | | |
| Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB) | CDER/CBER | May 2005 |
| | | |
| 2004 | | |
| Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (PDF - 734KB) | CDER/CBER/ORA | September 2004 |
| | | |
| 2003 | | |
DRAFT Guidance for Industry: Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information (PDF - 82KB)
| CBER/CDER/ CVM | September 2003 |
| DRAFT Guidance for Industry: Comparability Protocols -- Chemistry, Manufacturing, and Controls Information (PDF - 240KB) | CDER/CBER/CVM | Feburary 2003 |
| | | |
| 2002 | | |
Draft Guidance for Industry: CVM GFI #153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88KB)
| CBER/CDER/CFSAN/CDRH/CVM
Dept. of Agriculture/APHIS/CVB/BRS | September 2002 |
| Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers (PDF - 15KB) | CDER/CBER | May 2002 |
| | | |
| 2001 | | |
Guidance for Industry: IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF - 30KB)
| CDER/CBER | May 2001 |
| Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 30KB) | CDER/CBER | March 2001 |
| | | |
| 2000 | | |
| Draft Guidance for Industry: Analytical Procedures and Methods Validation Chemistry, Manufacturing, and Controls Documentation (PDF - 91KB) | CDER/CBER | August 2000 |
| | | |
| 1999 | | |
Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (PDF - 40KB)
| CDER/CBER/CDRH | July 1999 |
Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF - 8KB)
| CBER | August 1999 |
| Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB) | CDER/CBER | May 1999 |
| | | |
| 1998 | | |
Environmental Assessment of Human Drug and Biologics Applications (PDF - 188KB)
| CDER/CBER | July 1998 |
| Draft Guidance for Industry: Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (PDF - 150KB) | CDER/CBER/CVM | March 1998 |
| | | |
| 1996 | | |
| Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (PDF - 44KB) | CBER/CDER | August 1996 |
| | | |
| 1994 | | |
| Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (PDF - 57KB) | CDER/CVM | November 1994 |
| | | |
| 1993 | | |
| Guidance on Alternatives to Lot Release for Licensed Biological Products (PDF - 305KB) | CBER | July 1993 |
| | | |
| 1987 | | |
| Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For Human and Animal Parenteral Drugs, Biological Products and Medical Devices (PDF - 2874KB) (Withdrawn 6/22/2011) | CDER/CBER/CDRH/CVM | December 1987 |
| | | |
