FDA Archives

Blog

March 19, 2025 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the…

CertaraMarch 19, 2025

Blog

We look at the growing regulatory trend of rolling NDA and BLA submissions to help…

CertaraFebruary 3, 2025

Blog

Your biotech company has just submitted the marketing application for your first drug product. It’s…

CertaraOctober 25, 2024

Publication

The article from the European Journal of Pharmaceutical Sciences reviews the role of Physiologically Based…

CertaraSeptember 1, 2024

Blog

In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…

CertaraMay 10, 2024

Blog

Rare diseases are a public health priority. FDA has launched several programs and a final…

CertaraFebruary 21, 2024

Press Release

FDA holds more than 400 SimcypTM and PhoenixTM software licenses across 12 divisions and offices…

CertaraDecember 21, 2021

Blog

Do you get anxious about taking tests? Many people do because they want to show…

CertaraMay 25, 2017

FDA