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Abbreviated new drug applications (ANDAs) are subject to complying with requirements of FDA annual reporting—often the Q4 submission deadlines including blanket no-change certification (BNCC) or establishment registration (ER).
Each year pharmaceutical companies, including both manufacturers and private label distributors, are subject to...
The FDA has proposed new changes to the regulations regarding over-the-counter sunscreen products. Perhaps the most...
What is a New Drug Application (NDA)?Every new drug in the United States needs to come to market through a New Drug...
Recently, Reed Tech has been receiving many questions from our Pharma customers regarding the Over-The-Counter...
The NDC Directory is a comprehensive database containing information on prescription drugs, OTC medications, and insulin products in the U.S., identified by unique 10-digit National Drug Codes assigned by the FDA.
Co-Authored by David Wilson, Sr. Account Executive, Reed Tech, and Carolina Wirth, Of Counsel, Arnall Golden Gregory,...
For a thorough briefing on the latest with OTC Drug Reform and the CARES Act, we had a conversation with Carolina...
SingleSource™ for Drug Products helps regulatory professionals manage drug product meta-data with an intuitive...