The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders. You can read the FDA regulatory update for stakeholders below.
October 11, 2024
Dear Public Engagement Colleague,
The FDA continues its efforts in safeguarding the public against potential health risks, through utilizing peer reviewed evidence, and ensuring the safety and efficacy of medical products, we also recognize the invaluable work of our public engagement groups. The Public Engagement Staff will continue to work with our external partners so you can engage with the Office of the Commissioner and other FDA centers on priorities. Your partnership, knowledge and engagement in the public health space are appreciated.
You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.
When finalized, the guidance Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle is intended to provide recommendations on how patient preferences can be collected and shared with the FDA and be considered in decision-making. The guidance will also outline the types of patient preference studies that can provide reliable scientific evidence.
The Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) and the American Cancer Society (ACS) are co-sponsoring a symposium focusing on setting benchmarks for diversity in oncology clinical trials.
This webinar will present an overview of the end-to-end testing results for the Global Pharmaceutical Product Identification (PhPID) Service operating model, which generates global PhPIDs for marketed medicinal products. The session will detail the model's readiness for deployment, including its software functionality, interoperability, processes, and business rules.
Join previous FDA Commissioners and the FDA Oncology Center of Excellence, in recognizing a quarter century of federal government service by OCE Center Director, Dr. Richard Pazdur. The esteemed panel will highlight the many oncology advances and changes at FDA throughout Dr. Pazdur’s tenure.
The purpose of the public workshop is to exchange information with the medical and scientific community about the regulatory and scientific issues associated with use of live biotherapeutic products to prevent necrotizing enterocolitis (NEC) in very low birth weight (VLBW) infants.
The webinar will feature a panel of patients, care partners, and advocates discussing the following:
Experiences with their own support systems as they or a loved one participated in a clinical trial.
Tips on how to navigate logistical challenges, such as travel, when participating in a clinical trial.
Where and how to find support from friends and family, health care providers, clinical teams, employers, schools, patient advocacy groups, and other communities.
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts
About Us
The Public 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, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations. For more information, please contact us at: PublicEngagement@fda.hhs.gov. For patient specific inquiries, please contact us at: Patients Ask FDA.
October 11, 2024
