FDA’s New ANDA Submissions Guidance: Key Points Blog Post
The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance on September 24. The final guidance for industry titled, “ANDA Submissions – Content and Format” is…
Achieving Compliance with the FDA’s eCTD Mandate Blog Post
The US Food and Drug Administration (FDA) has set 2018 年 5 月 5 日 as the compliance date for submitting many types of files—Drug Master File (DMFs) and commercial investigational new drugs…
FDA’s New Module 1 is a Bridge to eCTD 4 Blog Post
Editor’s note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group that developed the Regulated Product Submissions (RPS) standard. This post is the third in a…
How to Prepare a Study Data Standardization Plan (SDSP) for FDA Blog Post
Get up-to-speed on Study Data Standardization Plan (SDSP) for FDA submissions. Read the blog post to find out more…
Modeling and Simulation for Medical Product Development and Evaluation: Highlights from the FDA-C-Path-ISOP 2013 Workshop Blog Post
Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative. Priorities identified…
FDA DataFit: an introduction Blog Post
Explore FDA DataFit, a project ensuring high-quality, compliant data to streamline drug reviews, reduce delays, and advance efficient decision-making.
FDA JumpStart: an introduction Blog Post
Discover FDA JumpStart, a ground-breaking service accelerating drug reviews by enhancing data quality, identifying risks, and streamlining submissions.
The Reference-scaled Average Bioequivalence (RSABE) Approach Blog Post
We examine the Reference-scaled Average Bioequivalence (RSABE) approach for generic drug development and how it compares with the standard approach.
