Results For "fda"

Certara Announces FDA Renewal and Expansion of Certara’s Biosimulation Software for Reviewing Regulatory Submissions Blog Post

FDA holds more than 400 SimcypTM and PhoenixTM software licenses across 12 divisions and offices PRINCETON, N.J.— 2021 年 12 月 21 日 – Certara, Inc. （纳斯达克股票代码：CERT), a global leader in biosimulation,…

FDA Submission Readiness Services Blog Post

FDA’s Digital Transformation: The Future of Technology and How to Prepare Blog Post

As Life-Science manufacturers embrace new technologies to speed time to market and products become more complex, the FDA has created an Office of Digital Transformation (ODT) to support the effective…

Organizing Complex Virology Datasets into FDA-Ready Format using SAS Programming Blog Post

运用先进 SAS 编程技术优化病毒学数据集整理流程。

FDA’s Digital Transformation Journey Blog Post

How New FDA Guidance Project Optimus May Affect Future of Oncology Clinical Trials, Drug Pipeline Blog Post

Julie Bullock, VP, global head of clinical pharmacology and translational medicine at Certara, discusses the FDA’s new guidance Project Optimus, which addresses issues relating to dose optimization in clinical trials...

Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program Blog Post

In 2018, the FDA’s Oncology Center of Excellence developed an Assessment Aid document to help facilitate review of New Drug Applications (NDAs)/Biologics License Applications (BLAs) (including supplements) submitted to the…

Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting Blog Post

Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory Committee meeting that took place on 2021 年 4 月 15 日 was not any different. The agenda…

Galderma Achieves FDA Approval of AKLIEF® (trifarotene) Blog Post

In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the topical treatment of acne. It is the only topical retinoid that selectively targets retinoic acid...

New Pinnacle 21 Community Validation Engine: FDA (1907.2) Blog Post

In August 2020, we released our new Pinnacle 21 validation engine “FDA (1907.2)” for preparing study data for FDA submissions. It includes the validation rules currently used by FDA’s DataFit,…