Glossary of Regulatory Terms Feb 2022 click to view Guidance Document In this Technical Brief: Topic(s): Regulatory Terms Glossary Region(s): United States
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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
Continue readingM3(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
Continue readingGuidance 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
Continue readingQ1A(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
Continue readingQuality 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
Continue readingSignificant 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
Continue readingAntiviral 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
Continue readingEnd-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
Continue readingFormal 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
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