What is a 505(b)(2)?
The 505(b)(2) New Drug Application (NDA) is a streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for…
Read MoreThe 505(b)(2) New Drug Application (NDA) is a streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for…
Read MoreQuantitative systems pharmacology (QSP) modeling can be an effective tool to solve a variety of drug development questions including understanding a drug’s mechanism of action, determining a drug’s biomarkers, and…
Read MoreInaccessibility, inadequate engagement, and lack of trust—these are just some of the issues that limit inclusion and lead to a lack of diversity in clinical trials. So, why is diversity…
Read MoreWhat is Cellular & Gene Therapy? Genes are defined by the NIH as the “basic physical and functional unit of heredity.” We receive these valuable sequences of DNA from our…
Read MoreDuring the current COVID-19 pandemic, it is important to find strategies to keep your drug development program moving forward. With many studies now paused, cancelled completely, or in the early…
Read MoreIf you missed our live panel discussion on how the drug development industry is being impacted by the COVID-19 pandemic, we have assembled this post to highlight some of the…
Read MoreWith the current COVID-19 pandemic, drug developers and researchers are searching for drug development strategies that limit human contact. For certain drugs and certain types of Phase 1 studies, a…
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