Updates
Guidance Documents - Request for Comment
Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
This guidance document provides FDA's recommendations on the information, technical performance assessment, and user information that should be included in a premarket submission for radiological devices that include quantitative imaging functions. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of premarket submissions for radiological devices that include quantitative imaging functions.
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. CBER encourages the use of appropriate standards in the development of CBER-regulated products.
Q9(R1) Quality Risk Management
Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are instrumental in enhancing the application of effective quality risk management by industry and regulators.
ICYMI!
June is PRIDE Month! LGBTQI+ Health & Well-being
HHS works to ensure that LGBTQI+ people, their families, and communities receive equal access to health services by providing enhanced resources for LGBTQI+ health issues; developing better information regarding LGBTQI+ health needs; and working to close the LGBTQI+ health disparities gap that currently exists.
Infant Formula Supply
 In the coming weeks and months, you should see more infant formula on store shelves as the FDA helps to increase supply to address production and distribution issues. Some of the products will be new to the U.S. market, and therefore new to you. It is important to talk with your child’s health care provider for recommendations on changing feeding practices as you consider your options.
The FDA and our government partners have created information resources to help you make decisions for feeding your baby until infant formula supplies return to normal.
Webinars and Virtual Workshops
Vaccines and Related Biological Products Advisory Committee
June 28, 2022; 8:30 AM - 5:00 PM ET
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified.
Registration is not required.
FDA Workshop: 7th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop
June 29, 2022; 10:00AM - 3:00 PM ET
The overarching aim of this year’s workshop remains the same as in past years - to provide a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the complex regulatory, health care policy, and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials.
Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Who to Ask and How to Ask
June 30, 2022; 11:00 AM - 1:00 PM ET
Speakers and participants will discuss a range of issues and best practices related to collecting patient input, selecting data collection methods, and developing sampling plans and strategies. External stakeholders will present examples of how they have used the guidance documents as tool to inform their collection of patient data. You may find a link to the referenced guidance documents here: PFDD Methodologic Guidance Documents.
Patient Engagement Advisory Committee Meeting Announcement
July 12 - 13, 2022
Day 1: 10:00 AM - 4:00 PM ET
Day 2: 10:00 AM - 2:00 PM ET
The FDA announces a forthcoming public advisory committee meeting of the CDRH Patient Engagement Advisory Committee. The general function of the committee is to provide advice to the Commissioner of Food and Drugs, or designee, on complex scientific issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public.
Registration is not required.
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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