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.
September 27, 2024
Dear Colleague,
While the FDA continues to focus on protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products, we also recognize the work of our public health partners. As public health advocates, we know that your work to better our country is invaluable. Your partnership, knowledge and engagement in the public health space are appreciated.
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 panel discussion takes place October 23, 2024, from 2:00 pm to 3:00 pm ET and will focus on Dr. Pazdur’s unceasing and continuing service to the global oncology community. During his 25 years of oncology leadership at the FDA, Dr. Pazdur has served with seven FDA Commissioners. Register now to watch this unique panel discussion with some of those FDA Commissioners and Dr. Pazdur.
The FDA published a digital health and artificial intelligence glossary as an educational resource to help support consistent use of digital health and artificial intelligence terminology by the FDA and interested parties (such as industry, digital health developers, academia, health care professionals, and patients).
Your friends at the gym can’t say enough about the bodybuilding products they’ve been taking to help build muscle mass and strength. You wonder, are they all safe to use?
The produce safety rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.
This guidance provides information regarding how basic safety and essential performance standards are incorporated into the Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Program).
The FDA was directed to issue a guidance regarding the goals and implementation of the ASCA Program in a pilot phase. FDA is concluding the ASCA pilot phase and establishing an ongoing ASCA Program, in accordance with amendments made to section 514 by section 2005 of the FDA User Fee Reauthorization Act of 2022, part of the Medical Device User Fee Amendments of 2022 (MDUFA V). The establishment of the goals, scope, procedures, and a suitable framework for the voluntary ASCA Program supports the Agency’s continued efforts to use its scientific resources effectively and efficiently to protect and promote public health.
This guidance provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Program).
This draft guidance document provides the FDA’s recommendations on analytical chemistry testing to assess the biocompatibility of medical devices. Chemical characterization is one approach that manufacturers can consider when developing a strategy for the overall biocompatibility assessment of a device. This guidance applies to methods for analytical chemistry testing of medical devices generally.
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.
ICYMI!
FDA in Your Day
Vaccines are the best way to protect yourself from getting certain diseases. But some people worry that some vaccines – like RSV and COVID-19 – are ‘just too new.’ While it’s natural to think about this, it's the FDA's job to determine their safety and effectiveness before they can be used in the U.S. and before your health care provider recommends them.
If you use tampons during your period (or menstruation), it’s important to know how to use them safely. Consider this important information from the U.S. Food and Drug Administration — and please share this information with other people who may use these products.
The purpose of this workshop is to engage with industry, academia, and FDA in a discussion on the scientific and regulatory challenges associated with immunogenicity risk assessment for proposed generic peptide and oligonucleotide drug products.
This webinar will discuss the ICH M12 Drug Interaction Studies guidance which is the first globally harmonized regulatory guidance on assessments of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters. The guidance describes a systemic approach to evaluation of the drug interaction potential of investigational drugs during drug development and regulatory review.
The FDA and the National Institutes of Health (NIH) will host a joint public meeting entitled, “Advancing Smoking Cessation: FDA and NIH Priorities”. The focus of the meeting is on advancing innovation of smoking cessation products to help both adults and youth.
The meeting will feature presentations and panel discussions on several smoking cessation-focused topics, including:
The FDA, the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) are announcing a public workshop entitled “Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants.” 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.
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts.
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. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov.
September 27, 2024
