For small and resource-constrained teams, outsourcing regulatory submission publishing can offer significant advantages.

The Electronic Common Technical Document (eCTD) has become the global standard for submitting regulatory information to agencies.

Thr Orange Book provides a comprehensive list of FDA-approved drug products and their therapeutic equivalence evaluations.

A detailed discussion of the clinical components in Modules 2 and 5 of the eCTD submission

This blog post will outline the structure and purpose of the nonclinical components of the eCTD.

Ever wonder how those harmonized guidelines that address the technical and scientific aspects of drug development come about? The...

Allison Steffen The recent DIA Regulatory Submissions, Information, and Document Management (RSIDM) Conference offered many practical...

Module 3, dedicated to Quality (Chemistry, Manufacturing, and Controls), is an important yet complex component of the eCTD.

The FDA ESG NextGen will be scalable, secure, more user-friendly, and designed to handle the full spectrum of electronic submissions.

FDA Validator Rules are technical criteria and guidelines applied by the U.S. FDA during regulatory submission review.

An Investigational New Drug (IND) application is a critical step for companies aiming to test their new drug candidates in humans....

Part two of a series about FDA approvals. In Part 1, covered the approval framework. Part 2 covers accelerated approvals.

In the world of drug development, the Food and Drug Administration (FDA) approval holds immense significance. It represents a meticulous...

In today's fast-paced and technology-driven environment, ensuring the efficient exchange of information between regulatory agencies and...

Getting your product’s regulatory submission ready to send to the FDA, Health Canada, or European health authorities can be...

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,...

Small pharmaceutical and biotech companies that are preparing to submit their first Investigational New Drug Application (IND) must make...

The U.S. FDA has published numerous resources that teams can access to understand the requirements for a submission in electronic Common...

Introduction In 2015, the concept of grouped submissions was introduced with the implementation of the US Module 1 specification v3.3....

The FDA ad promo guidance, Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and...