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

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

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

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

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

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

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

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

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

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