FDA Archives

Blog

2025 年 3 月 19 日 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the…

Mahumood Hameed2025 年 3 月 19 日

Blog

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

Evan Richardson2025 年 2 月 3 日

Blog

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

Danielle Pillsbury2024 年 10 月 25 日

Publication

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

Danielle Pillsbury2024 年 9 月 1 日

Blog

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

Jim Gallagher2024 年 5 月 10 日

Blog

罕见病是公共卫生领域的优先事项。FDA has launched several programs and a final…

Jim Gallagher2024 年 2 月 21 日

Press Release

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

Jim Gallagher2021 年 12 月 21 日

Blog

您是否对参加考试感到焦虑？Many people do because they want to show…

Certara2017 年 5 月 25 日

FDA