NYSDA Publications

FDA Issues Regulatory Update

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 Banner


June 10, 2022

Dear Colleague,

As you and other public health advocates work on the front lines of the COVID-19 pandemic, we want you to know that we recognize your concerns about protecting the safety of yourselves, your families, and others you care for. The FDA’s work is critical to ensuring the health and safety of the American public at any time, but is magnified during public health emergencies.

As we address the challenges of the COVID-19 pandemic, protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products continue to be top priorities for the FDA.

Stay up to date on Coronavirus Disease 2019 (COVID-19) by visiting the Resources for Health Professionals page.


 

Updates


SPOTLIGHT!

June is PRIDE Month! LGBTQI+ Health & Well-being

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HHS works to ensure that LGBTQI+ people, their families, and communities receive equal access to health services by providing enhanced resources for LGBTQI+ health issues; developing better information regarding LGBTQI+ health needs; and working to close the LGBTQI+ health disparities gap that currently exists.


Guidance Documents

Electromagnetic Compatibility (EMC) of Medical Devices

This guidance document provides the FDA’s recommendations on testing to assess the electromagnetic compatibility of medical devices and information to include in the labeling. This guidance applies to medical devices, including in vitro diagnostics, and accessories that are electrically powered or have functions or sensors that are implemented using electrical or electronic circuitry. The recommendations are intended to promote consistency and facilitate efficient review of electromagnetic compatibility in device submissions.


Consumer Updates

Infant Formula Supply

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In the coming weeks and months, you should see more infant formula on store shelves as the FDA helps to increase supply to address production and distribution issues. Some of the products will be new to the U.S. market, and therefore new to you. It is important to talk with your child’s health care provider for recommendations on changing feeding practices as you consider your options.

The FDA and our government partners have created information resources to help you make decisions for feeding your baby until infant formula supplies return to normal.


Products Marketed for Removing Moles and Other Skin Lesions Can Cause Injuries, Scarring

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As we get older, we can develop new growths on our skin that we may consider unattractive. These lesions are parts of the skin that look abnormal and include moles, seborrheic keratoses (wart-like growths), and skin tags. Removing them isn’t a do-it-yourself project, and it can be dangerous to try. Please see a health care provider to have them evaluated and removed, if necessary.

Currently, there are no FDA approved prescription or over-the-counter (OTC) drugs for treating moles, seborrheic keratoses, or skin tags. But there are potentially dangerous products being sold that claim to help remove these lesions. The products are sold as ointments, gels, sticks, and liquids and may contain high concentrations of salicylic acid (a chemical) or other harmful ingredients.


ICYMI!

Mixing Medications and Dietary Supplements Can Endanger Your Health

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When you take prescription or over-the-counter (OTC) medications, do you also take a vitamin, mineral, or other dietary supplement? Have you considered whether there is any danger in mixing medications and dietary supplements?

There could be. Certain dietary supplements can change absorption, metabolism, or excretion of a medication. If that happens, it can affect the potency of your medication, which means you may get either too much or too little of the medication you need.


Webinars and Virtual Workshops

Listening Sessions on FDA’s Proposed Product Standards Prohibiting Menthol in Cigarettes and Characterizing Flavors in Cigars

June 13 & 15, 2022; 10:00 AM - 4:00 PM ET

The sessions are an opportunity for the public to verbally provide open public comment on the agency’s proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and characterizing flavors (other than tobacco) in all cigars. Registration also includes a “listen-only” option for those who want to attend the sessions but do not want to request to speak.

Use the below links to request to speak or register to attend. Note that you must register separately for each day.

  • Submit a request to verbally provide open public comment on: June 13 or June 15
  • Register to attend in listen-only mode on June 13 or June 15

Speaking spots are limited, and we cannot guarantee we’ll be able to accommodate all requests. We ask that groups and organizations select a single spokesperson to help us hear as many different perspectives as possible. While speaking spots are limited, listening spots are unlimited.


Vaccines and Related Biological Products Advisory Committee

June 14 - 15, 2022; 8:30 AM - 5:00 PM ET

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss the following: On June 14, 2022, under Topic 1, the committee will meet in open session to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to children and adolescents 6 years through 17 years of age.

On June 15, 2022, under Topic II, the committee will meet in open session to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age, and also to discuss amending the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 4 years of age.

Registration is not required.


Advisory Committee Meeting Science Board to the FDA

June 14, 2022; 9:00 AM - 5:00 PM ET

The Science Board to the FDA will consider challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids as a case study. They will also hear about the Agency's enhanced efforts to spur the development, qualification, and adoption of new alternative methods for regulatory use that can replace, reduce, and refine animal testing and have the potential to provide both more timely and more predictive information to accelerate product development and enhance emergency preparedness.

Registration is not required.


Stakeholder Webinar on the Draft Guidance for Industry on Action Levels for Lead in Juice

June 14, 2022; 1:00 PM - 2:00 PM ET

The FDA is hosting this webinar to discuss the recent draft guidance on lead action levels for juice. The draft guidance, titled “Action Levels for Lead in Juice; Draft Guidance for Industry,” issued in April and provides action levels for lead in single-strength (ready to drink) apple juice and in other single-strength juices and juice blends. These draft action levels support the agency’s broader effort to reduce exposure to arsenic, lead, cadmium, and mercury from foods, and advance our goals in the Closer to Zero action plan.

During the webinar the FDA will provide an overview of the draft guidance and additional information, as well as answer stakeholder questions.


Webinar - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Draft Guidance

June 14, 2022; 1:00 PM - 2:15 PM

The FDA is announcing a webinar for stakeholders to share information and answer questions about the draft guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

Registration is not required.


Conversations on Cancer: "National Black Family Cancer Awareness Week: Engaging the Generations”

June 16, 2022; 1:00 PM - 2:30 PM ET

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The 2022 Conversations on Cancer: National Black Family Cancer Awareness Week public panel discussion is also in keeping with the Cancer Moonshot 2.0 which established goals to reduce cancer death rates by at least 50% over the next 25 years and improve the experience of living with and surviving cancer.

OCE is engaging NCI-designated Cancer Centers, cancer advocacy groups, patients, social and community organizers, Historically Black Colleges and Universities, families and friends. OCE’s Project Community is keenly interested in including members of all US communities in this dialogue.


Vaccines and Related Biological Products Advisory Committee

June 28, 2022; 8:30 AM - 5:00 PM ET

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified.

Registration is not required.


FDA Workshop: 7th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop

June 29, 2022; 10:00 AM - 3:00 PM ET

The overarching aim of this year’s workshop remains the same as in past years - to provide a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the complex regulatory, health care policy, and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials.


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.

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