Registration & Listings

Simplify drug registration and listings with comprehensive guidance and expert tips, so you can ensure full FDA compliance.

Master Files

Biologics

Registration & Listings

General Industry

Registration & Listings

Simplify drug registration and listings with comprehensive guidance and expert tips, so you can ensure full FDA compliance.

Master Files

Biologics

Registration & Listings

General Industry

Blog » Drugs » Registration & Listings

Featured Registration & Listings Articles

An Overview of FDA’s Regulations for OTC Human Drugs

Easily navigate FDA regulations for OTC human drugs with these expert insights into registration, listing, & marketing compliance.

Latest Registration & Listings Compliance Articles

FDA New Drug Applications (NDA): A Complete Guide to 505B1 Approval

Learn how to navigate the FDA’s 505B1 NDA process—from data requirements to approval timelines, labeling, and compliance. Avoid delays with expert guidance.

505B2 NDA Explained: A Strategic Pathway to FDA Drug Approval Using Existing Data

Learn how to leverage the 505B2 NDA pathway for faster FDA approval. Use existing data, reduce costs, and gain exclusivity for differentiated drug products.

Navigating eCTD Submissions: A Complete Guide for FDA Compliance and Global Strategy

Learn how to prepare eCTD submissions for FDA and global markets. Get up to speed on version 4.0, lifecycle tips, and best practices for compliance success.

Drug Establishment Registration: FDA Requirements, Responsibilities, and Strategic Considerations

Learn FDA drug establishment registration and listing rules, FEI use, and how to stay compliant under 21 CFR 207 for U.S. market access.

FDA Registration & Product Listing Guide for Indian Manufacturers

Navigate FDA registration & product listing for Indian pharma exporters. Ensure compliance, avoid delays, & fast-track U.S. market entry with expert guidance.

How FDA Approves and Clears Regulated Products

Learn the difference between FDA clearance and FDA approval and how they apply to medical devices and drugs.