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
Continue readingCategory Archives: Guidance Document
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
Continue readingGuidance 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
Continue reading