May 17, 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

• May 14, 2024 - FDA Roundup
• May 10, 2024 - FDA Roundup

Spotlight!

National Women’s Health Week (NWHW) is an annual observance that begins on Mother’s Day. This year, NWHW is observed May 12-18, 2024. NWHW is a reminder for women of all ages to prioritize their health. FDA Office of Women's Health (OWH) NWHW theme is “Know Your Bones”, to empower women to take charge of their bone health, including preventing and managing osteoporosis. It's never too early or too late to protect your bone health. 

FDA Voices

Protecting and Advancing the Health of Women Through Policy, Research, Education and Outreach

By: Robert M. Califf, M.D., Commissioner of Food and Drugs and Kaveeta P. Vasisht, M.D., PharmD, Associate Commissioner for Women’s Health and Director of the Office of Women’s Health

Thirty years ago, the FDA's Office of Women’s Health (OWH) was established to promote the inclusion of women in clinical trials and to provide leadership on topics related to the health of women. Since its inception in 1994, OWH has been at the forefront of ensuring that the unique health needs of women are prioritized through a multifaceted approach that encompasses policy, research, education, and outreach. In 2024, the office celebrates 30 years of service and paving a pathway to promote and support advancements in the health of women.

Furthermore, OWH has been instrumental in promoting diversity and the inclusion of women in clinical trials through its Diverse Women in Clinical Trials initiative. The initiative raises awareness about the importance of the participation of women of different ages, races, ethnic backgrounds, abilities, and those with chronic illnesses and health conditions in clinical trials. Although advancements have been made over the years, opportunities remain to further this progress.

Guidance Documents

Remanufacturing of Medical Devices

This final guidance is intended to help clarify whether activities performed on devices are likely “remanufacturing.”  This final guidance also clarifies existing regulatory requirements for remanufacturers and includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life.

View all Official FDA Guidance Documents and other Regulatory Guidance

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!

50th Biosimilar, Anti-choking Devices, New Initiative, High Blood Pressure | FDA In Your Day Ep. 4

Webinars and Virtual Workshops

Partnership for DSCSA Governance (PDG)/FDA Joint Public Meeting: DSCSA Stabilization Period Midway Checkpoint

June 17 - 18, 2024

Day 1: June 17, 2024; 12:30 - 5:30 p.m. ET
Day 2: June 18, 2024; 10:00 a.m. - 4:00 p.m. ET

The Partnership for DSCSA Governance (PDG) and FDA are hosting a joint public meeting on the Drug Supply Chain Security Act (DSCSA) implementation and stabilization efforts. This free meeting serves as a checkpoint midway in the stabilization period, affording industry, FDA and others an opportunity to share stabilization progress that has been made, stabilization activity that remains and areas of remaining concern.

FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference

June 18 - 20, 2024 

Day 1: Jun 18, 2024; 11:00 a.m. - 4:15 p.m. ET
Day 2: Jun 19, 2024; 11:00 a.m. - 4:15 p.m. ET
Day 3: Jun 20, 2024; 11:00 a.m. - 4:15 p.m. ET

This three-day virtual conference is intended to share information among FDA representatives and the regulated community to facilitate the understanding of regulations, guidelines and practices, and to suggest methods and opportunities to enhance the research professional’s product development experience.

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.