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 13, 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 FDA for the First National Hispanic/Latino Family Cancer Awareness Week, Sept. 20-26
By: Luckson Mathieu, MD, Senior Clinical Reviewer, DO2, OND; Donna Rivera, PharmD, Associate Director for Pharmacoepidemiology, Oncology Center of Excellence (OCE), and Rea Blakey, Associate Director for External Outreach and Engagement, OCE
Project Community within the U.S. Food and Drug Administration’s Oncology Center of Excellence (OCE) will hold the first National Hispanic/Latino Family Cancer Awareness Week Sept. 20-26, 2024, to increase cancer awareness within the Hispanic/Latino population. The week will feature a virtual Conversation on Cancer public panel discussion and a social media campaign using the hashtag #LatinoCancer. National Hispanic/Latino Family Cancer Awareness Week aims to gather community-based groups to increase cancer awareness and build knowledge surrounding cancer clinical trial participation as well increase the understanding of ways to contribute to national genetic databases for cancer research. The discussion brings together experts involved in health care for Hispanic/Latino communities, advocates, communicators and FDA oncologists, to focus on addressing cancer disparities.
This guidance describes how sponsors and applicants must organize the content that they submit to the Agency electronically for all submission types under section 745A(a) of the FD&C Act. This guidance also references several technical specification documents and the electronic common technical document (eCTD) Technical Conformance Guide, which provide additional details regarding the organization of content for electronic submissions.
This guidance is intended to explain to applicants how the assessment goals established as part of the Generic Drug User Fee Amendments of 2022 (GDUFA III) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to the Food and Drug Administration under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).
The FDA issued this guidance to describe the processes available to mammography facilities to request additional review of an adverse appeals decision on a facility’s accreditation, and/or a suspension or revocation of certificate, and/or a patient and referring provider notification (PPN) order.
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!
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Emergencies and disasters such as hurricanes, floods, lightning storms, earthquakes, and fires can affect everyone from people who rely on medical devices, to companies that manufacture medical devices, to shipping and delivery operators who get medical devices to our doors.
Despite advances in cancer prevention and precision cancer care, cancer is the leading cause of death for the Hispanic population in the US. Cancer accounts for the death of about 23,800 Hispanic men and 22,700 Hispanic women. Hispanic individuals have higher rates of infection-related cancers, including approximately two-fold higher incidence of liver and stomach cancer compared to Non-Hispanic White (NHW) individuals.
Join us for the 2024 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. The workshop will also highlight innovative science and cutting-edge methodologies in generic drug development both within the U.S. and globally.
On September 24, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar to provide information on how to comply with labeling requirements for IVDs, including LDTs. The focus of this webinar will be on labeling requirements for test systems, under 21 CFR 809.10(b) and will not cover labeling requirements for other types of IVDs such as collection devices and general purpose reagents.
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 13, 2024
Project Community within the U.S. Food and Drug Administration’s Oncology Center of Excellence (OCE) will hold the first National Hispanic/Latino Family Cancer Awareness Week Sept. 20-26, 2024, to increase cancer awareness within the Hispanic/Latino population. The week will feature a virtual Conversation on Cancer public panel discussion and a social media campaign using the hashtag #LatinoCancer. National Hispanic/Latino Family Cancer Awareness Week aims to gather community-based groups to increase cancer awareness and build knowledge surrounding cancer clinical trial participation as well increase the understanding of ways to contribute to national genetic databases for cancer research. The discussion brings together experts involved in health care for Hispanic/Latino communities, advocates, communicators and FDA oncologists, to focus on addressing cancer disparities.
