Lance's Corner

FDA Issues Health Care Stakeholders Update

Jul 28, 2025

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.

July 28, 2025

Dear Colleague,

The FDA works to safeguard the public against potential health risks, ensures the safety and efficacy of medical products, and the safety of our nation’s food supply and cosmetics.  Your partnership, knowledge and engagement in the public health space are appreciated.

Sincerely,

The Public Engagement Staff
Public Engagement Staff | FDA

Updates

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

The FDA’s medical product safety reporting program for health professionals, patients and consumers.  MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products.  The most recent alerts/recalls are:

Guidance Documents

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.

FDA Direct

FDA Welcomes Dr. Tidmarsh as Center for Drug Evaluation and Research (CDER) Director

New!  FDA Direct, Episode 13 - Stanford Physician-Scientist: FDA welcomes Dr. Tidmarsh as CDER Director

Listen as FDA Commissioner, Dr. Marty Makary, speaks with Dr. George Tidmarsh, the new Director of FDA’s Center for Drug Evaluation and Research about the future of drug regulation at the FDA.

ICYMI!

July is Fibroids Awareness Month

FDA Office of Women’s Health (OWH) is raising awareness about uterine fibroids—the most common non-cancerous tumors that grow in and around the wall of the uterus of women of childbearing age.  OWH offers a range of resources to promote education, awareness, and advance research on uterine fibroids—including a fact sheet, educational and personal story videos, and information on treatment options to support informed care.

Webinars and Virtual Workshops

FDA Grand Rounds – Forensic Proteomics Applied to FDA-Regulated Products

Date: Thu, July 31, 2025; noon - 1 p.m. ET

Proteins and peptides are being increasingly used in therapeutic formulations.  This presentation will discuss the techniques utilized at the National Forensic Chemistry Center to analyze proteins and peptides in FDA-regulated products.

Register for the FDA’s Public Meeting on the Reauthorization of the Medical Device User Fee Amendments

Date: Mon, Aug. 4, 2025; 10 a.m. - 3 p.m. ET

The FDA is announcing a public meeting on the reauthorization of the Medical Device User Fee Amendments for fiscal years 2028 through 2032 (MDUFA VI).

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

Date: Wed, Aug. 13, 2025; 9 a.m. - 3:30 p.m. ET

On August 13, 2025, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Committee) will discuss a new indication for use for dermal filler devices in the décolletage area and will make recommendations regarding risks associated with new indications for use such as in the décolletage area, the potential impact of filler material on imaging studies and clinical exams (e.g., breast cancer screening), pre-market and post-market study assessments for benefit and risk, removal of dermal filler implant material, and patient preference.

Compounding Quality Center of Excellence | Annual Conference

Day1: Mon, Aug. 25, 2025; 2 - 5 p.m. ET
Day 2: Wed, Aug. 27, 2025; 9 a.m. - 6 p.m. ET
Day 3: Thu, Aug. 28, 2025; 9 a.m. - 4:30 p.m. ET

FDA’s Compounding Quality Center of Excellence will host its sixth Annual Conference.  Participants can attend this free, hybrid conference in person at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Maryland, or virtually.  The conference will convene outsourcing facilities, pharmacy compounders and others from across the industry to discuss emerging trends and best practices through presentations, panels and interactive sessions.

Collaborating on Food Safety Culture

Date: Webinar Series 2 from Wed, Sept. 3, 2025 - Wed, Sept. 16, 2026; noon ET

The FDA and the Alliance to Stop Foodborne Illness, a non-profit public health organization, are collaborating on a webinar series that explores food safety culture.  The series, entitled Collaborating on Food Safety Culture, began on November 4, 2021.  The webinar series engages experts from the public and private sectors in a collaborative exchange of ideas and experiences related to the importance of a robust food safety culture in helping to ensure safe food production.  The series will have valuable information for both those well-versed on, and those just learning about, food safety culture.

Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act

Date: Mon, Sept. 15, 2025; 9 a.m. - 4:30 p.m. ET

The purpose of the public meeting is to seek input from interested parties including, patient/parent/caregiver groups, consumer groups, regulated industry, academia, and others.  This input will enable FDA to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, including pediatric drug and biologic development and labeling, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA).

FDA Public Meeting: BsUFA III Regulatory Science Program Interim Public Meeting

Date: Thu, Sept. 18, 2025; 9 a.m. - 3 p.m. ET

The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual meeting on September 18, 2025, to meet the BsUFA III Commitment to review the progress of the pilot program’s aims, or demonstration projects, and solicit input on future priorities.  The meeting agenda includes an overview of the regulatory science program, presentations by internal and external awardees conducting research projects under the BsUFA III regulatory science program, and panel discussions by FDA staff and representatives from the biosimilar industry.

FDA CBER OTP Public Listening Meeting: Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies

Date: Thu, Sept. 18, 2025; 10 a.m. - 4 p.m. ET

The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public listening meeting to solicit perspectives from cell and gene therapy (CGT) manufacturers and other stakeholders on leveraging prior knowledge and experience to facilitate product development and application review.

FDA Public Workshop: Future Needs for the Development of Interchangeable Products

Date: Fri, Sept. 19, 2025; 9 a.m. - 1 p.m. ET

The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual public workshop on September 19, 2025, to meet the BsUFA III commitment.  The meeting agenda includes presentations by representatives from the biosimilar industry on the future needs for the development of interchangeable products, discussions on specific interchangeable topics, and a panel discussion with industry.

FDA/The Osteosarcoma Institute (OSI) Workshop: Advancing Osteosarcoma Drug Development – Connecting Research and Regulatory Pathways for Improved Outcomes

Date: Fri, Oct. 10, 2025; 9:30 a.m. - 5 p.m. ET

The FDA Oncology Center of Excellence (OCE) and The Osteosarcoma Institute (OSI) have a shared interest in engaging with the osteosarcoma community to identify the major barriers to drug development for osteosarcoma and to discuss opportunities for collaboration to address these challenges.

View Upcoming FDA Meetings, Conferences and Workshops

Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

About Us

The Public 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, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations.  For more information, please contact us at: PublicEngagement@fda.hhs.gov.  For patient specific inquiries, please contact us at: Patients Ask FDA.

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.

Download the guide

Accommodation and Compliance: Long COVID

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.

Read the brief

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.

Download the policy brief

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.

Download the report

Working with Long COVID

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.

Download the fact sheet

COVID-19: Long-Term Symptoms

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.

Watch the motion graphic

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.

Listen to the podcast

HHS OIG Issues Annual Report on State MFCUs

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 Fiscal Year 2023 Annual Report (OEI-09-24-00200) 

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.

Read the Full Report

View the Statistical Chart

Engage with the Interactive Map

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)

CMS Issues Latest Medicare Regulatory Activities Update

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