Results For "fda"

Accelerating Oncology Drug FDA Submission with Project Management Services Blog Post

Discover how Certara’s dedicated project management and pharmacometric support helped an emerging biotech company fast-track FDA submission for a first-in-class oncology drug via the Real-Time Oncology Review (RTOR) program—shortening timelines by two months.

FDA ESG NextGen for Regulatory Submissions Blog Post

The FDA ESG NextGen for Regulatory Submissions has replaced the FDA’s WebTrader and simplifies pharmaceutical registration and submission management.

您是否已为 FDA 逐步淘汰单抗（mAbs）动物试验做好准备？ Blog Post

演讲嘉宾：Fran Brown, PhD Senior Vice President, Certara Drug Development Solutions Fran has over 25 years of experience with strategic and operational global drug development from early discovery to filing...

FDA to phase out animal testing with AI and lab-based models Blog Post

FDA aims to replace animal testing in drug development with AI and lab-based models, enhancing safety, lowering costs, and expediting treatments.

FDA plans to phase out animal testing requirements Blog Post

Discover how the FDA plans to replace animal testing with AI and organ-on-chip technologies for more accurate and ethical drug development.

FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format Blog Post

Peggy Zorn 2025 年 3 月 19 日 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the structure and implementation rules for submitting computer-readable datasets to regulatory agencies. SEND is...

How the US FDA MIDD paired pilot program helps sponsors Blog Post

Rajesh Krishna, PhD 2025 年 2 月 28 日 For the past couple of decades, leading American institutions, pharmaceutical and biotechnology companies, as well as the US FDA have been using quantitative tools...

How to Validate Your Clinical Data Using FDA Validation Rules Blog Post

Erin Erginer 2025 年 1 月 30 日 For clinical data managers, understanding clinical data validation and applying FDA validation rules are essential to ensuring regulatory compliance, improving study efficiency and maintaining data...

Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters Blog Post

Rajesh Krishna, PhD 2025 年 1 月 10 日 Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A defect in the Frataxin (FXN) gene causes FA. FXN is essential for...

How Modeling Was Used to Support the FDA Approval of a Topical Generic Drug Product Blog Post

Establishing bioequivalence for topical drug products can be challenging and costly, often requiring extensive comparative clinical endpoint studies that may not effectively capture formulation differences. However, the FDA’s recent approval…