Why Early-Stage Biotech and Pharma Teams Should Outsource Regulatory Publishing
For small and resource-constrained teams, outsourcing regulatory submission publishing can offer significant advantages.
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Oct 24 min read
The Complexity of eCTD Compliance: Common Challenges and Practical Solutions
The Electronic Common Technical Document (eCTD) has become the global standard for submitting regulatory information to agencies.
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Aug 284 min read
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 234 min read
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 265 min read
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 143 min read
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 193 min read
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 15 min read
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, 20233 min read
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, 20233 min read
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, 20233 min read
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, 20234 min read
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 20, 20234 min read
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, 20234 min read
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, 20235 min read
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, 20225 min read
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, 20224 min read
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, 20224 min read
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, 20224 min read
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, 20221 min read
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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