FDA Stakeholder Update - February 6, 2020

Dear Colleague, FDA's Stakeholder Engagement Staff works to provide you with up-to-date information to further our commitment to advance public health and well-being.

FDA Announcement

FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic

The FDA issued an emergency use authorization (EUA) to enable emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; this authorization allows the use of the test at any CDC-qualified lab across the country. [02/04/2020]

FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products to Help Americans

The FDA and the Federal Trade Commission signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products. This joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space. [02/03/2020]

FDA approves first drug for treatment of peanut allergy for children

The FDA approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Treatment with Palforzia may be initiated in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals 4 years of age and older. Those who take Palforzia must continue to avoid peanuts in their diets.  [01/31/2020]

FDA in Brief

FDA Updates Prioritization Policy for Original Abbreviated New Drug Applications, Amendments and Supplements to Maximize Impact on Public Health

The following quote is attributed to Sally Choe, Ph.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research:

“The U.S. Food and Drug Administration is making critical updates to our policy for prioritizing the review of abbreviated new drug applications (ANDAs) to advance the public health, efficiently allocate limited agency resources and ensure fairness to applicants, which reflects the FDA’s longstanding practice to prioritize the review of ANDAs that would have the greatest potential impact on public health, if approved. [1/30/2020]

Public Meetings and Workshops

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

Date: February 24, 2020

Time: 9:00 AM - 5:00 PM ET

Location: FDA White Oak Campus: The Great Room Conference Center, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993

Agenda: The FDA Rare Disease Day 2020 meeting will include perspectives from various stakeholders in rare disease product development. The specific goal of this meeting is to identify challenges and solutions in rare disease product development to optimize rare disease medical product development. 

Register: If you wish to attend in-person or via webcast, please register at Eventbrite.

Public Workshop - Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine

Date: March 5, 2020

Time: 8:30 AM - 5:00 PM ET

Location: FDA White Oak Campus: The Great Room Conference Center, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993

Agenda: The purpose of the public workshop is to discuss evaluation techniques for hardware, standards development, and assessment challenges for applications of Extended Reality (XR) in medicine. The goal is to identify critical gaps that may impede medical XR device development, innovation, and to advance the evaluation of medical XR devices and applications, thus accelerating the development of safe and effective medical XR devices benefiting patients and healthcare. 

Register: If you wish to attend this workshop, you must register by 4:00 PM on February 28, 2020.

FDA/FTC Workshop on a Competitive Marketplace for Biosimilars

Date: March 9, 2020

Time: 9:00 AM - 5:00 PM ET

Location: FDA White Oak Campus: The Great Room Conference Center, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993

Agenda: The purpose of the public workshop is to discuss FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and deter anticompetitive behaviors in the biologic marketplace. 

Register: If you wish to attend in-person or via webcast, please register at Eventbrite.

For a more comprehensive list of public meetings involving the FDA, please visit here.