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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.
After an 829 day wait from the initial draft guidance, the FDA has issued the long-awaited Final Guidance on Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food,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...
Recently, Reed Tech subject-matter experts, Gary Saner and David Wilson, hosted a webinar to provided a recap of what this new deadline means for pharma companies and how to ensure compliance, as well as explained the implications of recent updates and the progress of the draft guidance.
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).