Washington, DC – The FDA will host Rare Disease Day, a virtual public meeting, on March 1, 2024 in global observance of Rare Disease Week. This year’s Rare Disease Day is dedicated to patients and health care professionals. Panels will discuss:
- The legal framework for approving studies and medical products at FDA
- What FDA does during review processes to approve medical products
- Decentralized clinical trials and digital health technologies
- Where to find important information and documents related to clinical trials
- Information that can be obtained from medical product labels
- Legal and ethical requirements for consent forms in clinical trials
- FDA initiatives to advance medical product development for rare diseases
- Ways for patients to engage with FDA
Continuing education credit
Free continuing education (CE) credit is available for physicians, physician assistants, pharmacists, pharmacy technicians, nurses, and certified public health professionals who attend FDA’s Rare Disease Day. This event is approved for 4.25 CE credit hours.
Public docket
Stakeholders are invited to provide their perspectives on the discussion questions through the public docket. All comments must be identified with the docket number FDA-2023-N-5211 through April 5, 2024.
Contact
Participants may submit questions in advance to [email protected].
Office of Clinical Policy and Programs, Office of Orphan Products Development | 301-796-7634