Navigating the FDA disruption: 4 key actions for pharma

Tune in as Glenn Hunzinger, PwC’s Health Industries Leader, connects with Matt Rich, PwC’s Pharma and Life Sciences R&D Leader, to unpack the recent disruption at the FDA and what it means for the pharmaceutical and biotech sectors. They discuss how companies can stay agile in the face of regulatory uncertainty, avoid preventable delays, and take practical steps to move programs forward with clarity.

Discussion highlights:

• Ongoing restructuring at the FDA is creating uncertainty and delays in drug and device approvals, with wide-ranging impacts across the pharma, biotech and medtech landscape.
• While companies can’t control the regulatory environment, they can focus on improving internal speed, efficiency, and submission quality to keep programs moving forward
• Avoiding preventable missteps, or “foot faults,” in data, endpoints, and submission packages is critical to reducing review delays and regulatory pushback
• Diversifying risk by pursuing parallel regulatory pathways in other regions such as Europe and Japan can help accelerate access and reduce dependency on a single agency
• In the absence of a clear playbook, companies should focus on what they can control by applying past lessons, staying disciplined, and collaborating across the industry to support more efficient FDA review processes

Speakers:

Matt Rich, PwC’s Pharmaceutical and Life Sciences R&D Leader
Glenn Hunzinger, Partner, Health Industries Leader, PwC

Linked materials:

Navigating the FDA disruption: 4 key actions for pharma

For more information, please visit us at: https://www.pwc.com/us/en/industries/health-industries/health-research-institute/next-in-health-podcast.html.