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Drug & Biologic Product Submissions

Drug & Biologic Product Submissions

Drug & Biologic Product Submissions

National Drug Code (NDC) Assignment Guide

Drug Establishment Registration Reporting Requirements

Reed Tech SPL Solutions

FDA now accepting REMS in SPL format

FDA now accepting REMS in SPL format

Beginning today, September 2, 2016, the FDA is accepting REMS (Risk Evaluation and Mitigation Strategy) submissions in Structured Product Labeling (SPL) format. SPL is an XML document markup standard approved by Health Level 7 and previously adopted by the FDA for...

FDA UDI Enforcement

FDA UDI Enforcement

How will the FDA enforce the requirements of the UDI Final Rule? This video details what the FDA has said so far and what we can expect for UDI policing based on prior agency enforcement...

Electronic Lot Distribution Reports Are More Complex Than You Think

Electronic Lot Distribution Reports Are More Complex Than You Think

New FDA regulations for submitting electronic Lot Distribution Reports (LDRs) went into effect June 10, 2015. They apply to all companies that market products in the U.S. under a Biologics License Application (BLA). Some companies must submit their first reports in...

3 Options for Managing Biologic Lot Distribution Reports (LDR)

3 Options for Managing Biologic Lot Distribution Reports (LDR)

It is not new that the FDA requires the submission of Lot Distribution Reports (LDRs) for all products marketed in the U.S. under a Biologics License Application (BLA). However, it is important for BLA holders to know that a new FDA LDR submission format will soon be...

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