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 Pushback on Accelerated Gene Therapy Approvals
In this episode, Edye Edens dives into the FDA’s evolving scrutiny of accelerated approvals in gene therapy and rare diseases. Using the example of Sarepta’s muscular dystrophy treatment, she explains how postmarket safety issues and incomplete confirmatory trials can put previously celebrated approvals under renewed FDA evaluation.
Edye breaks down three common pitfalls sponsors face:
- Lagging confirmatory trials
- Outdated safety monitoring plans
- Poor communication across teams and with FDA
She offers practical guidance to avoid regulatory setbacks:
- Build flexible governance frameworks
- Stay proactive with FDA engagement
- Plan for legal and regulatory risks in confirmatory trials
- Prepare for public, regulatory, and payer scrutiny post-approval
Accelerated approval is a major milestone—but it’s not the end. It's the beginning of the next regulatory chapter. Tune in to learn how to manage post-approval responsibilities and secure long-term success for your therapy.
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