DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
FDA Regulatory Submissions: Challenges, Trends, and Future Predictions
Edye Edens from KLF offers a brief yet in-depth overview of FDA regulatory submissions for clinical research in the U.S., reflecting on both current practices and predictions for 2025. She highlights how AI tools and evolving political dynamics are shaping the regulatory landscape, emphasizing that while efficiency improvements are necessary, careful and strategic approaches are critical to maintain the FDA’s global reputation and safety standards.
Edye discusses the complexity of submissions like Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, noting the significant preclinical work, detailed documentation, and thorough FDA review process involved. She also underscores the global weight of FDA approvals, as many international regulatory bodies rely on FDA assessments as a benchmark.
Finally, Edye poses key questions to her audience:
- How familiar are you with regulatory submissions?
- Are you considering outsourcing this complicated process?
- Where do you see opportunities for efficiency—through AI, technology, or administrative changes?
- If you’ve been a reviewer, how do you balance efficiency with safety?
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