Food and Drug Administration (FDA)

FDA Comment Deadline: Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development

The Food and Drug Administration (FDA) is seeking comments to accompany the public meeting titled “FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development.” Developing a treatment for a rare disease can present unique challenges. The goal of this meeting is to obtain stakeholder’s perspectives on challenges and solutions in rare disease product development and identify commonalities that can support product development across a variety of rare diseases. For more information on meeting content, please see this FDA draft agenda.

Members of the public may submit comments online at Regulations.gov, or by mail. More information is available at this FDA website.

FDA Comment Deadline: Office of Minority Health and Health Equity Strategic Priorities

The Food and Drug Administration (FDA) is opening a public docket to solicit input and comments from interested stakeholders, including racial and ethnic minority, underrepresented, and underserved populations, in establishing strategic priorities for the Office of Minority Health and Health Equity (OMHHE). This will help the FDA ensure that important health concerns are carefully considered in establishing priorities.

FDA's OMHHE serves to promote and protect the health of diverse populations through research and communication of science that addresses health disparities and health equity. Established in 2010, OMHHE provides leadership and policy direction for FDA regarding issues relating to the health of racial and ethnic minority, underrepresented, and underserved populations. OMHHE's stakeholders reflect the diversity of the US population, including individuals of low socioeconomic status and historically underrepresented populations.

Members of the public may submit comments electronically through Regulations.gov, or by mail. For more information about the docket in question, please see this Federal Register notice.

FDA Workshop: Evolving Role of Artificial Intelligence in Radiological Imaging

The Food and Drug Administration (FDA) is announcing a public workshop entitled "Evolving Role of Artificial Intelligence in Radiological Imaging." The intent of this public workshop is to discuss emerging applications of Artificial Intelligence (AI) in radiological imaging including AI devices intended to automate the diagnostic radiology workflow as well as guided image acquisition. The purpose of the workshop is to work with interested stakeholders to identify the benefits and risks associated with use of AI in radiological imaging. FDA also plans to discuss best practices for the validation of AI-automated radiological imaging software and image acquisition devices. Validation of device performance with respect to the intended use is critical to assess safety and effectiveness.

Members of the public may attend in person or via webcast. For more information on the workshop, please see this FDA website and agenda.

FDA Meeting: Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development

The Food and Drug Administration (FDA) is announcing a public meeting titled “FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development.” Developing a treatment for a rare disease can present unique challenges. The goal of this meeting is to obtain stakeholder’s perspectives on challenges and solutions in rare disease product development and identify commonalities that can support product development across a variety of rare diseases. For more information on meeting content, please see this FDA draft agenda.

Members of the public may attend the meeting in person or via webcast with advance registration. More information is available at this FDA website.

FDA Drafts Guidance on Demonstrating Substantial Evidence of Effectiveness

Regulatory Focus — Specifically, the 18-page draft guidance builds on FDA’s 1998 guidance Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products, which detailed FDA’s expectations for evidence to support the approval of new drugs and biologics or applications for supplemental indications in light of FDAMA’s clarification that a single adequate and well-controlled clinical trial and confirmatory evidence can be used to support app