Simplifying Global Compliance
What CDER Can and Can’t Do: An Inside Look from an Agency Official - Webinar Recording/Transcript
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What CDER Can and Can’t Do: An Inside Look from an Agency Official
CDER, the FDA’s drug-approval arm, pays attention to patient and caregiver input … and so should you.
Starting in the ‘90s and strengthened by the 2012 FDASIA law, CDER has been making concerted efforts to take patient views into account. FDAnews has asked an insider, Dr. Sadhna Khatri, to show you how that process works … and how it affects your new-product approvals.
Dr. Khatri shows you what CDER has done, what it wishes to do, and what law and regulation prevent it from doing. Over a fast-paced hour and a half, she’ll examine:
- The patient voice: What CDER does to help patients get heard on drug approval, safety and efficacy issues
- Speedier review: What CDER can do to speed approvals
- What CDER can’t do: Limitations placed by law and regulation
- FDASIA: How the 2012 law expands and strengthens agency ability to safeguard public health …
- Real-world examples: Engagement strategies that work for others
- How to deal with CDER: Face-to-face, electronically and via postal mail
- How to request a meeting with CDER
- And MUCH more!
Patients experience diseases and therapies differently. Each has his/her own perspective on treatments and diagnostic procedures. For successful new-drug applications, it’s essential to understand the patient perspective. An agency outreach specialist shows you what to focus on.
- Quality professionals
- Regulatory/compliance
- Patient advocates
- Health care professionals
CDR Sadhna Khatri, PharmD MPH MS MEd is a regulatory officer in Professional Affairs and Stakeholder Engagement (PASE), Office of the Center Director, CDER, where she evaluates a wide range of drug safety issues with an eye toward mitigating risk and its impact on public health. She develops strategic contacts and outreach to other agencies, professional organizations and societies, and works with patient advocates to increase engagement with the FDA and strengthen the patient voice in the drug development process. Previously she was associated with CDER’s Division of Drug Information, responding to public inquiries, and FDA’s MedWatch program. She was also director of the FDA’s Pharmacy Student Experiential Program (PSEP).
