The FDA's Orange Book
Thr Orange Book provides a comprehensive list of FDA-approved drug products and their therapeutic equivalence evaluations.
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- Jul 23
- 4 min
What are the Clinical Components of the eCTD?
A detailed discussion of the clinical components in Modules 2 and 5 of the eCTD submission
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- Jun 26
- 5 min
What’s Included in the Nonclinical Portions of the eCTD?
This blog post will outline the structure and purpose of the nonclinical components of the eCTD.
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- May 14
- 3 min
The ICH Process for Developing Guidelines
Ever wonder how those harmonized guidelines that address the technical and scientific aspects of drug development come about? The...
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- Mar 19
- 3 min
Reflections from the 2024 DIA RSIDM Conference
Allison Steffen The recent DIA Regulatory Submissions, Information, and Document Management (RSIDM) Conference offered many practical...
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- Mar 1
- 5 min
What are the Quality (CMC) Components of the eCTD?
Module 3, dedicated to Quality (Chemistry, Manufacturing, and Controls), is an important yet complex component of the eCTD.
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- Dec 11, 2023
- 3 min
What We Can Expect with the FDA’s ESG NextGen Project
The FDA ESG NextGen will be scalable, secure, more user-friendly, and designed to handle the full spectrum of electronic submissions.
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- Nov 2, 2023
- 3 min
FDA Study Data Validator Rules for Electronic Regulatory Submissions
FDA Validator Rules are technical criteria and guidelines applied by the U.S. FDA during regulatory submission review.
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- Aug 29, 2023
- 3 min
Five Challenges that Early-Stage Companies Should Consider When Planning for Their First IND
An Investigational New Drug (IND) application is a critical step for companies aiming to test their new drug candidates in humans....
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- Jul 12, 2023
- 4 min
Drug Development Designation for FDA Accelerated Approvals - Part 2
Part two of a series about FDA approvals. In Part 1, covered the approval framework. Part 2 covers accelerated approvals.
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- Jun 21, 2023
- 4 min
FDA Approvals: Understanding the Process and Designations for Safe and Effective Medications: Part 1
In the world of drug development, the Food and Drug Administration (FDA) approval holds immense significance. It represents a meticulous...
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- Apr 10, 2023
- 4 min
The FDA Electronic Submissions Gateway: Kicking Off the FDA Review Process
In today's fast-paced and technology-driven environment, ensuring the efficient exchange of information between regulatory agencies and...
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- Jan 9, 2023
- 5 min
Considerations When Evaluating eCTD Submission Publishing and Management Vendors
Getting your product’s regulatory submission ready to send to the FDA, Health Canada, or European health authorities can be...
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- Nov 15, 2022
- 5 min
PDUFA: 30 Years and Counting
The Prescription Drug User Fee Act (PDUFA) was signed into law in 1992 by George H. W. Bush, as an amendment to the Federal Food, Drug,...
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- Oct 6, 2022
- 4 min
Should Small Pharma and Biotech Companies Build Regulatory Operations Capabilities?
Small pharmaceutical and biotech companies that are preparing to submit their first Investigational New Drug Application (IND) must make...
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- Aug 15, 2022
- 4 min
FDA Resources to Support Your Next eCTD Submission
The U.S. FDA has published numerous resources that teams can access to understand the requirements for a submission in electronic Common...
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- Apr 28, 2022
- 4 min
Ad Promo Series: Using Grouped Submissions for Multi-Product Advertising Materials
Introduction In 2015, the concept of grouped submissions was introduced with the implementation of the US Module 1 specification v3.3....
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- Apr 18, 2022
- 1 min
Updates to the FDA’s Ad Promo Guidance
The FDA ad promo guidance, Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and...
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- Feb 21, 2022
- 1 min
eCTD Module 1 Specification Reminder
O March 1, 2022, the US FDA will no longer be accepting the eCTD Module 1 specification v1.3 (US regional DTD v2.01)
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- Apr 6, 2021
- 5 min
The Basics of BIMO
Introduction If you have submitted an initial marketing application in the US over the past few years, you may have included a BIMO data...
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