Lance's Corner

FDA Issues Health Care Stakeholders Update

Aug 30, 2024

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.

FDA Stakeholder Update BannerAugust 30, 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

Spotlight!

FDA OVERDOSE PREVENTION FRAMEWORK

 

Food and Drug Administration Overdose Prevention Framework

The FDA Overdose Prevention Framework consists of four overarching priorities that align with the U.S. Department of Health & Human Services' Overdose Prevention Strategy to address the public health emergency as it continues to evolve. The overdose crisis is an evolving public health crisis; as such, FDA continues to evaluate our approach and make adjustments according to the latest available science and data.

Consumer Updates

MAN SLEEPING CPAP MACHINE

 

Do You Need a Device That Claims to Clean a CPAP Machine?

Most CPAP accessories such as hoses or tubes and masks can be cleaned with only mild soap and water. Follow your CPAP manufacturer's instructions. The FDA is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices due to potential health risks. We have answers to your questions related to this CPAP recall.

spilling_the_beans_how_much_caffeine_is_too_much_1600x900_0

 

Spilling the Beans: How Much Caffeine is Too Much?

According to medical experts, including here at the FDA, caffeine can be part of a healthy diet for most people, but too much of it can have negative effects and large amounts may pose a danger to your health. Depending on factors such as body weight, medications you may take, certain medical conditions, and individual sensitivity, “too much” can vary from person to person. Be aware of the level of caffeine in your diet and look out for signs when it’s too much.

Guidance Documents

Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

FDA is issuing this guidance to help manufacturers further understand and utilize the Voluntary Summary Malfunction Reporting Program, an established voluntary program by which manufacturers may submit certain malfunctions related to devices with certain product codes to FDA in a summary format on a quarterly basis.

CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology

This guidance document provides guidance on characteristics for consideration during the validation of the analytical procedures included as part of registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States.

CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: Methodology

This guidance is complementary to GFI #63 (VICH GL1), which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. The purpose of this document is to provide some guidance and recommendations on how to consider the various validation characteristics for each analytical procedure included as part of a registration application for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States.

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!

FDA In Your Day
FDA In Your Day

Chief Medical Officer, Dr. Hilary Marston discusses Lyme disease. 

Webinars and Virtual Workshops

Webinar – Draft Guidance: Predetermined Change Control Plans for Medical Devices

September 3, 2024; 1 p.m. - 2:30 p.m. ET

FDA will host a webinar for industry and other interested stakeholders to answer questions about the draft guidance: Predetermined Change Control Plans for Medical Devices.

Registration is not necessary.

Please click the link to join the webinar. Passcode: b.0Acb

FDA NIH: Regulatory Do's and Don'ts: Tips from FDA

September 4, 2024; 11 a.m. - 3 p.m. ET

The webinar aims to educate early-stage companies (small businesses) new to the regulatory landscape at the FDA. This activity is intended to provide an overview on resources and programs that FDA has developed across CBER, CDER, and CDRH that can help academic life-science accelerators and early-stage, oncology-related companies, develop new anticancer-therapeutics, devices, and diagnostics. 

OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs

September 5, 2024; 11 a.m. - 12:30 p.m. ET

FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall. In this event, experts from OTP’s Office of Cellular Therapy and Human Tissue CMC will answer questions regarding development and readiness of chemistry, manufacturing, and controls (CMC) data and information for late-stage investigational new drug applications (INDs) – INDs intended to collect primary evidence of effectiveness to support a marketing application for cell therapy and tissue-engineered products.

ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients

September 6, 2024; 9 a.m. - 5 p.m. ET

FDA in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI) is convening this one-day workshop to solicit input from stakeholders on increasing the enrollment of historically underrepresented populations in pediatric clinical studies, and encouraging pediatric clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups, where appropriate and other topics.

National Hispanic/Latino Family Cancer Awareness

National Hispanic/Latino Family Cancer Awareness. An Oncology Center of Excellence Project Community Initiative #LatinoCancer

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

The FDA's Oncology Center of Excellence Project Community will hold the inaugural National Hispanic/Latino Family Cancer Awareness Week on September 20-26, 2024. The week will feature a Conversation on Cancer public panel discussion on September 20, and a social media campaign throughout the week using the hashtag #LatinoCancer. 

CBER listening session graphic

Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases

September 20, 2024; 11 a.m. - 4:30 p.m. ET

The FDA Center for Biologics Evaluation and Research (CBER) is hosting a public patient listening meeting and opening a docket to better understand patient and care partner perspectives on safety considerations and long-term follow-up for approved gene therapy treatments for rare diseases.

Virtual Patient Engagement Advisory Committee Meeting Announcement on Patient-Centered Informed Consent in Clinical Study

October 30, 2024; 10 a.m. - 5 p.m. ET

The FDA is announcing a virtual Patient Engagement Advisory Committee (the Committee) meeting on Patient-Centered Informed Consent in Clinical Study. The general function of the Committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform.

If you have questions about this virtual public meeting, contact Letise Williams.

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.

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