CMC and GMP Guidances

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• Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry
  CDER/CBER, December 2023

• Translation of Good Laboratory Practice Study Reports: Questions and Answers; Draft Guidance for Industry
  CDER/CBER/CDRH/CVM/CFSAN/CTP/ORA, November 2023

• Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry
  CDER/CBER/CVM, October 2023

• Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol; Guidance for Industry
  CDER/CBER/CVM, October 2023

• Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Draft Guidance for Industry
  CDER/CBER, September 2023

• Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA; Guidance for Industry
  CDER/CBER, October 2022

• Changes to Disposable Manufacturing Materials: Questions and Answers; Guidance for Industry
  CDER/CBER/CVM, July 2022

• Drug Products, Including Biological Products, that Contain Nanomaterials; Guidance for Industry
  CDER/CBER, April 2022

• Inspection of Injectable Products for Visible Particulates; Draft Guidance for Industry
  CDER/CBER/CVM, December 2021

• CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Guidance for Industry
  CDER/CBER, December 2021

• ICH Q12: Implementation Considerations for FDA-Regulated Products; Draft Guidance for Industry
  CDER/CBER/CDRH, September 2021

• Field Alert Report Submission: Questions and Answers; Guidance for Industry
  CDER/CBER, July 2021

• Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry
  CBER/CDER, June 2021

• Bispecific Antibody Development Programs; Guidance for Industry
  CDER/CBER, May 2021

• Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products; Draft Guidance for Industry
  CDER/CBER, May 2021

• Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19); Guidance for Industry
  CDER/CBER/CVM, January 2021

• Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products; Draft Guidance for Industry
  CDER/CBER,  July 2020

• Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing; Guidance for Industry
  CDER/CBER/CVM, June 2020

• Drug Master Files; Draft Guidance for Industry
  CDER/CBER, October 2019

• Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers; Guidance for Industry
  CDER/CBER, October 2019

• Data Integrity and Compliance With Drug CGMP - Questions and Answers; Guidance for Industry 
  CDER/CBER/CVM/CGMP, December 2018 

• 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
  CDER/CBER/CDRH, October 2018  

• Elemental Impurities in Drug Products; Guidance for Industry
  CDER/CBER, August 2018

• Osteoarthritis: Structural Endpoints for the Development of Drugs; Draft Guidance for Industry
  CDER/CBER/CDRH, August 2018

• Drug Products, Including Biological Products, that Contain Nanomaterials; Draft Guidance for Industry
  CDER/CBER, December 2017

• Clinical Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations; Draft Guidance for Industry
  CDER, October 2017

• Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry
  CDER/CBER, October 2017

• CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Draft Guidance for Industry
  CDER/CBER, August 2017

• Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance
  OCP/CBER/CDER/CDRH/ORA, January 2017

• Submission of Quality Metrics Data; Draft Guidance for Industry
  CDER/CBER. November 2016

• Contract Manufacturing Arrangements for Drugs: Quality Agreements; Guidance for Industry
  CDER/CBER/CVM, November 2016

• Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry
  CBER, June 2016

• Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry
  CDER/CBER, April 2016

• Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry
  CDER/CBER, July 2015

• Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products; Guidance for Industry
  CDER/CBER, June 2015

• Process Validation: General Principles and Practices; Guidance for Industry
  CDER/CBER/CVM, January 2011

• Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes; Guidance for Industry
  CDER/CVM/CBER, February 2010

• Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
  CBER/CDER, November 2008

• Current Good Manufacturing Practice for Phase 1 Investigational Drugs; Guidance for Industry
  CDER/CBER/ORA, July 2008

• Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms
  CBER, September 2007

• Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations; Guidance for Industry
  CDER/CBER/CVM/ORA, September 2006

• Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA; Guidance for Industry
  CDER/CBER/CVM/ORA, January 2006

• Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients; Guidance for Industry
  CDER/CBER, May 2005

• Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice; Guidance for Industry
  CDER/CBER/ORA, September 2004

• Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers; Guidance for Industry
  CDER/CBER, May 2002

• IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information; Guidance for Industry
  CDER/CBER, May 2002

• Monoclonal Antibodies Used as Reagents in Drug Manufacturing; Guidance for Industry
  CDER/CBER, March 2001

• Possible Dioxin/PCB Contamination of Drug and Biological Products; Guidance for Industry
  CDER/CBER/CVM, August 1999

• Container Closure Systems for Packaging Human Drugs and Biologics; Guidance for Industry
  CDER/CBER, May 1999

• Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA); Guidance for Industry
  CDER/CBER/CDRH, February 1999

• Environmental Assessment of Human Drug and Biologics Applications; Guidance for Industry
  CDER/CBER, July 1998

• Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
  CBER/CDER, July 1997

• 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
  CBER/CDER, August 1996

• FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products; Availability 
  CBER, July 1995

• Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products; Guidance for Industry
  CDER/CVM, November 1994