Drug & Biologic Product Submissions

This page provides blogs, short videos and recordings focused on industry insights for regulatory requirements and best practices for electronic submission compliance for manufacturers and distributors of drug and biologic products.

National Drug Code (NDC) Assignment Guide

Drug Establishment Registration Reporting Requirements

Reed Tech Structured Product Labeling Solutions

FDA Drug Distribution Amounts Report: Frequently Asked Questions and More

FDA Drug Distribution Amounts Report: Frequently Asked Questions and More

Public Dashboard Now Available for REMS Data

Public Dashboard Now Available for REMS Data

Missed FDA Annual Deadlines? It’s not too late to keep your drug active!

Missed FDA Annual Deadlines? It’s not too late to keep your drug active!

Updated Deadline: FDA Announces New Annual Drug Distribution Reporting Requirement

Updated Deadline: FDA Announces New Annual Drug Distribution Reporting Requirement

FDA Withdraws 216 ANDAs

FDA Withdraws 216 ANDAs

Overview of Pharma Annual Deadlines and Requirements

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Overview of Pharma Annual Deadlines and Requirements

Proposed Changes to OTC Sunscreen GRASE and Labeling Regulations

Proposed Changes to OTC Sunscreen GRASE and Labeling Regulations

Overview of Pharma Annual Deadlines and Requirements

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Achieving Compliance: Pharma Year-End Requirements

New Drug Application (NDA): Back to the Basics

New Drug Application (NDA): Back to the Basics

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