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Glossary of Regulatory Terms

Glossary of Regulatory Terms

Glossary of Regulatory Terms Feb 2022 click to view Guidance Document In this Technical Brief: Topic(s): Regulatory Terms Glossary Region(s): United States

Principles of Premarket Pathways for Combination Products

Principles of Premarket Pathways for Combination Products

Principles of Premarket Pathways for Combination Products – Guidance for Industry and FDA Staff January 2022 click to view Guidance Document In this Technical Brief: Health Risk(s): Combination Products Product Type(s): Combination Topic(s): Regulatory Issues Region(s): United States

Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, Center for Drug Evaluation and Research Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products Visit Guidance Document January 2022
Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”

Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”

Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” September 2020 click to view Guidance Document In this Technical Brief: Product Type(s): Medical Devices Topic(s): Product Development Regulatory Issues Region(s): United States

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research Visit Guidance Document September 2020
ISO 14971: 2019 — Medical devices: Application of risk management to medical devices

ISO 14971: 2019 — Medical devices: Application of risk management to medical devices

Medical devices: Application of risk management to medical devices   December 2019 click to view Guidance Document In this Technical Brief:     Product Type(s): Medical Devices Topic(s): Regulatory Issues Region(s): United States

Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy: Guidance for Industry

Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy: Guidance for Industry

Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy: Guidance for Industry July 2019 click to view Technical Brief In this Technical Brief: Health Risk(s): Unintended Pregnancy Product Type(s): Hormonal Contraceptives Topic(s): Product Development Regulatory Issues Region(s): United States

Office of Communications, Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration. Visit Guidance Document July 2019
Bioanalytical Method Validation: Guidance for Industry

Bioanalytical Method Validation: Guidance for Industry

Bioanalytical Method Validation: Guidance for Industry May 2018 click to view Guidance Document In this Technical Brief: Product Type(s): Drug Development Topic(s): Bioanalytical Methods Region(s): United States

Center for Drug Evaluation and Research, Center for Veterinary Medicine Visit Guidance Document May 2018
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: Guidance for Industry

Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: Guidance for Industry

Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: Guidance for Industry Dec 2017 click to view Guidance Document In this Technical Brief: Product Type(s): Drug Development Topic(s): Prescription Drug User Fee Act Region(s): United States

Center for Drug Evaluation and Research Visit Guidance Document December 2017
Guideline on clinical development of fixed combination medicinal products

Guideline on clinical development of fixed combination medicinal products

Guideline on clinical development of fixed combination medicinal products March 2017 click to view Guidance Document In this Technical Brief: Product Type(s): Fixed combination medicinal products containing two or more active substances within a single pharmaceutical form Topic(s): Product Development Regulatory Issues Region(s): United States

Committee for Human Medicinal Products (CHMP), European Medicines Agency. Visit Guidance Document March 2017
Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products

Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products

Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products January 2017 click to view Guidance Document In this Technical Brief: Product Type(s): Combination Products Topic(s): Manufacturing MPTs Regulatory Issues Region(s): United States

U.S. Department of Health and Human Services, Food and Drug Administration, Office of Combination Products (OCP) in the Office of the Commissioner, Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Office of Regulatory Affairs (ORA) Visit Guidance Document January 2017
Guidance for Industry – Vaginal Microbicides: Development for the Prevention of HIV Infection

Guidance for Industry – Vaginal Microbicides: Development for the Prevention of HIV Infection

Guidance for Industry – Vaginal Microbicides: Development for the Prevention of HIV Infection November 2014 click to view Technical Brief In this Technical Brief: Health Risk(s): HIV Product Type(s): ARVs Microbicides Topic(s): Product Development Regulatory Issues Region(s): United States

U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Visit Guidance Document November 2014
Codevelopment of Two or More New Investigational Drugs for Use in Combination

Codevelopment of Two or More New Investigational Drugs for Use in Combination

Codevelopment of Two or More New Investigational Drugs for Use in Combination June 2013 click to view Guidance Document In this Technical Brief: Product Type(s): MPTs Topic(s): Product Development Regulatory Issues Region(s): United States

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Visit Guidance Document June 2013
ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals

ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals

ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals June 2011 click to view Guidance Document In this Technical Brief: Product Type(s): Pharmaceuticals Topic(s): Preclinical Safety Regulatory Issues Region(s): United States

European Medicines Agency Visit Guidance Document June 2011
M3(R2): Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

M3(R2): Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

M3(R2): Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals January 2010 click to view Guidance Document In this Technical Brief: Product Type(s): Pharmaceuticals Topic(s): Human Clinical Trials Region(s): United States

Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research Visit Guidance Document January 2010
ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals

ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals

ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals December 2009 click to view Guidance Document In this Technical Brief: Product Type(s): Pharmaceuticals Topic(s): Human Clinical Trials Marketing Authorization Regulatory Issues Region(s): United States

European Medicines Agency Visit Guidance Document December 2009
End-of-Phase 2A Meetings: Guidance for Industry

End-of-Phase 2A Meetings: Guidance for Industry

End-of-Phase 2A Meetings Sept 2009 click to view Guidance Document In this Technical Brief: Product Type(s): Drug Development Topic(s): Phase 2A Region(s): United States

Center for Drug Evaluation and Research Visit Guidance Document September 2009
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations

Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations

Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations October 2006 click to view Guidance Document In this Technical Brief: Product Type(s): Pharmaceuticals Topic(s): Manufacturing Practice Regulations Region(s): United States

Center for Veterinary Medicine, Office of Regulatory Affairs, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research Visit Guidance Document October 2006
Antiviral Product Development: Conducting and Submitting Virology Studies to the Agency

Antiviral Product Development: Conducting and Submitting Virology Studies to the Agency

Antiviral Product Development: Conducting and Submitting Virology Studies to the Agency June 2006 click to view Guidance Document In this Technical Brief: Product Type(s): Antiviral Topic(s): Virology Studies Antiviral Product Development Region(s): United States

Center for Drug Evaluation and Research Visit Guidance Document June 2006
Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors

Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors

Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors January 2006 click to view Guidance Document In this Technical Brief: Product Type(s): Medical Device Topic(s): IRB Clinical Investigator Sponsor Information Sheet Region(s): United States

Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice, Center for Devices and Radiological Health Visit Guidance Document June 2006
Nonclinical Safety Evaluation of Drug or Biologic Combination

Nonclinical Safety Evaluation of Drug or Biologic Combination

Nonclinical Safety Evaluation of Drug or Biologic Combination March 2006 click to view Guidance Document In this Technical Brief: Product Type(s): Combination Topic(s): Nonclinical Safety Evaluation Regulatory Issues Region(s): United States

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Visit Guidance Document March 2006
Guideline on clinical investigation of steroid contraceptives in women

Guideline on clinical investigation of steroid contraceptives in women

Guideline on clinical investigation of steroid contraceptives in women July 2005 click to view Guidance Document In this Technical Brief: Product Type(s): Steroid Contraceptives Topic(s): Clinical Investigation Product Development Regulatory Issues Region(s): United States

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency Visit Guidance Document July 2005
Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives

Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives

Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives July 2005 click to view Guidance Document In this Technical Brief: Health Risk(s): STDs Vaginal Contraceptives Product Type(s): Combination Vaginal Contraceptives Topical Drugs Topic(s): Pharmacology / Toxicology […]

Division of Reproductive and Urologic Drug Products, Office of Drug Evaluation II, Division of Anti-infective Drug Products and Division of Antiviral Drug Products, Office of Drug Evaluation IV Visit Guidance Document July 2005
Q1A(R2) Stability Testing of New Drug Substances and Products

Q1A(R2) Stability Testing of New Drug Substances and Products

Q1A(R2) Stability Testing of New Drug Substances and Products November 2003 click to view Guidance Document In this Technical Brief: Product Type(s): New Drug Substances and Products Topic(s): Stability Testing Q1A (R2) Region(s): United States

Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research Visit Guidance Document November 2003
Guidance for the Development of Vaginal Contraceptive Drugs (NDA)

Guidance for the Development of Vaginal Contraceptive Drugs (NDA)

Guidance for the Development of Vaginal Contraceptive Drugs (NDA) March 1995 click to view Guidance Document In this Technical Brief: Product Type(s): Vaginal Contraceptives Topic(s): Development of Vaginal Contraceptives Region(s): United States

Center for Drug Evaluation and Research Visit Guidance Document March 1995