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.
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.
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.
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.
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.
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.
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.
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.
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.
USDOL Issues Comprehensive Employer Guidance on Long COVID
The United States Department of Labor (USDOL) has issued a comprehensive set of resources that can be accessed below for employers on dealing with Long COVID.
Supporting Employees with Long COVID: A Guide for Employers
The “Supporting Employees with Long COVID” guide from the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) and Job Accommodation Network (JAN) addresses the basics of Long COVID, including its intersection with mental health, and common workplace supports for different symptoms. It also explores employers’ responsibilities to provide reasonable accommodations and answers frequently asked questions about Long COVID and employment, including inquiries related to telework and leave.
The Long COVID Accommodation and Compliance webpage from the USDOL-funded Job Accommodation Network (JAN) helps employers and employees understand strategies for supporting workers with Long COVID. Topics include Long COVID in the context of disability under the Americans with Disabilities Act (ADA), specific accommodation ideas based on limitations or work-related functions, common situations and solutions, and questions to consider when identifying effective accommodations for employees with Long COVID. Find this and other Long COVID resources from JAN, below:
Long COVID, Disability and Underserved Communities: Recommendations for Employers
The research-to-practice brief “Long COVID, Disability and Underserved Communities” synthesizes an extensive review of documents, literature and data sources, conducted by the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) on the impact of Long COVID on employment, with a focus on demographic differences. It also outlines recommended actions organizations can take to create a supportive and inclusive workplace culture for people with Long COVID, especially those with disabilities who belong to other historically underserved groups.
Long COVID and Disability Accommodations in the Workplace
The policy brief “Long COVID and Disability Accommodations in the Workplace” explores Long COVID’s impact on the workforce and provides examples of policy actions different states are taking to help affected people remain at work or return when ready. It was developed by the National Conference of State Legislatures (NCSL) as part of its involvement in USDOL’s State Exchange on Employment and Disability (SEED) initiative.
Understanding and Addressing the Workplace Challenges Related to Long COVID
The report “Understanding and Addressing the Workplace Challenges Related to Long COVID” summarizes key themes and takeaways from an ePolicyWorks national online dialogue through which members of the public were invited to share their experiences and insights regarding workplace challenges posed by Long COVID. The dialogue took place during summer 2022 and was hosted by USDOL and its agencies in collaboration with the Centers for Disease Control and Prevention and the U.S. Surgeon General.
The USDOL-published “Working with Long COVID” fact sheet shares strategies for supporting workers with Long COVID, including accommodations for common symptoms and resources for further guidance and assistance with specific situations.
This USDOL motion graphic informs workers with Long COVID that they may be entitled to temporary or long-term supports to help them stay on the job or return to work when ready, and shares where they can find related assistance.
A Personal Story of Long COVID and Disability Disclosure
In the podcast “A Personal Story of Long COVID and Disability Disclosure,” Pam Bingham, senior program manager for Intuit’s Diversity, Equity and Inclusion in Tech team, shares her personal experience of navigating Long COVID symptoms at work. The segment was produced by the USDOL-funded Partnership on Employment and Accessible Technology (PEAT) as part of its ongoing “Future of Work” podcast series.
Per the notice below, the Office of the Inspector General (OIG) of the United States Department of Health and Human Services (HHS) has issued its annual report on the performance of state Medicaid Fraud Control Units (MFCUs).
Medicaid Fraud Control Units (MFCUs) investigate and prosecute Medicaid provider fraud and patient abuse or neglect. OIG is the Federal agency that oversees and annually approves federal funding for MFCUs through a recertification process. This new report analyzed the statistical data on annual case outcomes—such as convictions, civil settlements and judgments, and recoveries—that the 53 MFCUs submitted for Fiscal Year 2023. New York data is as follows:
Outcomes
Investigations1 - 556
Indicted/Charged - 9
Convictions - 8
Civil Settlements/Judgments - 28
Recoveries2 - $73,204,518
Resources
MFCU Expenditures3 - $55,964,293
Staff on Board4 - 257
1Investigations are defined as the total number of open investigations at the end of the fiscal year.
2Recoveries are defined as the amount of money that defendants are required to pay as a result of a settlement, judgment, or prefiling settlement in criminal and civil cases and may not reflect actual collections. Recoveries may involve cases that include participation by other Federal and State agencies.
3MFCU and Medicaid Expenditures include both State and Federal expenditures.
4Staff on Board is defined as the total number of staff employed by the Unit at the end of the fiscal year.
GAO Issues Report on Medicaid Managed Care Service Denials and Appeal Outcomes
The United States Government Accountability Office (GAO) has issued a report on federal use of state data on Medicaid managed care service denials and appeal outcomes. GAO found that federal oversight is limited because it doesn't require states to report on Medicaid managed care service denials or appeal outcomes and there has not been much progress on plans to analyze and make the data publicly available. To read the GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the first link below. To read GAO highlights of the report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the second link below. https://www.gao.gov/assets/d24106627.pdf (GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes) https://www.gao.gov/assets/d24106627_high.pdf (GAO highlights on federal use of state data on Medicaid managed care service denials and appeal outcomes)
The Centers for Medicare and Medicaid Services (CMS) has issued its latest update on its regulatory activities in the Medicare program. While dentistry is only minimally connected to the Medicare program, Medicare drives the majority of health care policies and insurance reimbursement policies throughout the country. Therefore, it always pays to keep a close eye on what CMS is doing in Medicare. To read the latest CMS update on its regulatory activities in Medicare, use the link below. https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-03-14-mlnc