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.

Updates

• September 12, 2024 - FDA Adds Warning about Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause
• September 12, 2024 - FDA Approves Atezolizumab and Hyaluronidase-tqjs for Subcutaneous Injection
• September 12, 2024 - FDA Authorizes First Over-the-Counter Hearing Aid Software
• September 11, 2024 - FDA Issues Warning Letters to Two Chinese Firms Regarding Data Quality and Integrity Concerns, Violative Lab Practices
• September 10, 2024 – CDER Conversation: Streamlining Drug Development and Improving Patient Care: CDER Quantitative Medicine Center of Excellence
• September 10, 2024 - MQSA Final Rule Now in Effect
• September 10, 2024 - FDA Roundup

FDA Voices

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.

Guidance Documents

Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry

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.

ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA

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)).

Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders

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.

View all Official FDA Guidance Documents and other Regulatory Guidance

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ICYMI!

Want to be better prepared for emergencies? Check out these tips.

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.

Webinars and Virtual Workshops

FDA Oncology Center of Excellence Presents: Conversations on Cancer: National Hispanic Family Cancer Awareness Week

September 20, 2024; 11:00 a.m. - 12:00 p.m. ET

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.

KEYNOTE SPEAKER

Advancing Generic Drug Development: Translating Science to Approval 2024

September 24 - 25, 2024

Day 1: Tue, Sep 24; 8:30 a.m. - 4:35 p.m. ET
Day 2 : Wed, Sep 25; 9:00 a.m. - 4:15 p.m. ET

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.

Webinar - Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b)

September 24, 2024; 1 - 2 p.m. ET

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.

Registration is not necessary

Public Meeting on the Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food

September 25, 2024; 12:30 – 4:30 p.m. ET

The FDA is developing a systematic process for conducting post-market assessments of chemicals in food. This includes ingredients considered generally recognized as safe (GRAS), food additives, color additives, food contact substances, and contaminants. This is intended to guide our post-market assessment work going forward and includes a transparent process for identifying and prioritizing food chemicals currently in the market for safety reviews.

View Upcoming FDA Meetings, Conferences and Workshops

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.