AI has the potential to revolutionize healthcare, and the FDA wants to ensure that patient safety remains the top priority while fostering these cutting-edge advancements. That’s where their four areas of focus come in – collaboration, regulatory clarity, standards and best practices and research.
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FDA Releases Drug Amount Report Final Guidance and Updated Deadlines
After an 829 day wait from the initial draft guidance, the FDA has issued the long-awaited Final Guidance on Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act – or as Reed Tech has taken to...
FDA Drug Distribution Amounts Report: Frequently Asked Questions and More
In late 2021, the US Food and Drug Administration (FDA) is instited a new annual distribution report, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, for all listed drugs. According to...
FDA Withdraws 216 ANDAs
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). Due to non-compliance with these annual...
Reed Tech SingleSource™ for Drug Products and Schlafender Hase® TVT®, the Text Verification Tool®
Reed Tech and Schlafender Hase® are leaders in the life sciences industry, working together to help ensure that pharmaceutical companies and their products are compliant with global regulatory standards. Both companies understand and solve industry challenges with...