Rolling NDA and BLA Submissions: Accelerate Your Review Timeline
We look at the growing regulatory trend of rolling NDA and BLA submissions to help…
Evan Richardson2025 年 2 月 3 日
Anonymization vs. Redaction of Clinical Trial Data
2025 年 1 月 17 日 The vernacular for disclosing pharmaceutical clinical trial results to the public may…
Becca Bucci2025 年 1 月 17 日
CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know
2024 年 12 月 3 日 The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for…
Danielle Pillsbury2024 年 12 月 3 日
ICH M12 Guidelines & Your Drug-Drug Interaction Package
We have provided an overview of the key changes to the ICH M12 drug-drug interaction…
Danielle Pillsbury2024 年 6 月 19 日
Demystifying CDISC, SDTM, and ADaM
Breaking down the basics of CDISC’s CDASH, SDTM and ADaM standards, to help you understand…
Nathan Teuscher2024 年 5 月 22 日
什么是 FDA Project Optimus？它会如何影响肿瘤药物开发？
Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…
Jim Gallagher2022 年 2 月 2 日
