Updates
FDA Media Call - Replay: Oral Antiviral Treatments for COVID-19
 View FDA's media call highlighting the Emergency Use Authorizations of two new oral antivirals for the treatment of mild-to-moderate COVID-19.
Guidance Documents - Request for Comment
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
FDA is issuing this draft guidance to provide its recommendations and expectations to manufacturers of devices that were issued EUAs to transition back to normal operations when the emergency use declarations that allowed for FDA to issue EUAs are no longer in effect. FDA believes the policy set forth in this guidance may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and processes.
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
FDA is issuing this draft guidance to provide its recommendations and expectations to manufacturers of devices that fell within enforcement policies to transition back to normal operations when the public health emergency expires. FDA believes the policy set forth in this guidance may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and processes.
ICYMI!
Curriculum Materials for Health Care Degree Programs | Biosimilars
 FDA’s curriculum materials are intended to help educate students in health care professional degree programs, for medicine, nursing, physician assistants, and pharmacy, as well as practicing professionals, to improve understanding of biosimilar and interchangeable biosimilar products and the regulatory approval pathway in the United States. The Resource Guide for Teaching Faculty provides information for instructors who would like to incorporate topics related to biosimilar and interchangeable biosimilar products into the education and training they provide students.
Webinars and Virtual Workshops
Development and Testing of Warnings for Tobacco Products: Scientific and Regulatory Considerations
This presentation will discuss the current regulatory landscape of tobacco product warnings through CTP’s authority. We will examine the development and testing of warnings for cigarettes that resulted in the March 2020 final rule “Required Warnings for Cigarette Packages and Advertisements” with a focus on the scientific and regulatory considerations that went into that research and development plan for those warnings.
January 13, 2022; 12:00 PM - 1:00 PM ET
Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C (NPC) Public Workshop
The FDA and Duke-Margolis will host a virtual public workshop on endpoint considerations to facilitate drug development for NPC. During this workshop, participants will discuss clinical endpoints relevant to NPC clinical trials and innovative strategies to support therapeutic development for patients with NPC. The workshop is open to the public and will include representation from the patient community, health care providers, industry, and other federal partners.
January 24 - 25, 2022; 12:00 PM - 3:30 PM ET
About Us
The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations.
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