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


October 7, 2022

Dear Colleague,

As you and other public health advocates work on the front lines, 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.

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.


 

Updates


Consumer Updates

Treating and Preventing Head Lice

child scratching their head

Head lice affect millions of children every year. Schoolchildren are commonly affected by head lice, which attach to hair and feed on human blood.

“Although head lice are a year-round problem, the number of cases usually peaks during back-to-school time in the fall and again in January,” says Patricia Brown, M.D., a dermatologist at the FDA.

Here are some tips to protect your children and your family from this menace.


Infant Formula Supply

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The FDA continues efforts to increase the supply of infant formula production in the U.S.

As part of the efforts, imported infant formula that’s been reviewed by the FDA is showing up on store shelves and on the websites of formula companies and major retailers.

Because these products are new to the U.S. market, and therefore new to you, you may have questions about them. It is important to talk with your child’s health care provider for advice and the appropriate formulas to substitute as you consider your options.


FDA Voices

FDA Takes Steps to Further Harmonize Clinical Research Regulations with HHS Common Rule

Human Subjects

By: Hilary Marston, M.D., M.P.H., Chief Medical Officer and Ann Meeker-O’Connell, M.S., Director, Office of Clinical Policy (pictured below)

Clinical trials play a crucial role in advancing science and supporting the development of new medical products to address unmet patient needs. Reliable data from well-designed trials about a medical product’s safety and effectiveness are critical to the FDA’s decision-making about a product’s benefits and risks.

Hilary Martson_900x900.pngIn general, clinical trials, particularly advanced stage trials, that enroll participants reflecting the diversity of patient populations will help make it possible to apply the findings from clinical trials to broader patient populations and maximize the public health impact of FDA cleared or approved products.

 


FDA Outlines Work Underway to Ensure the Safety of Imported Produce

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By: Donald Prater, Associate Commissioner for Imported Food Safety and Julie Moss, Director of the Office of International Engagement in the Center for Food Safety and Applied Nutrition (pictured below)

A lot of the food that American consumers eat and serve their families is imported from other countries. Of the foods subject to oversight by the FDA, fresh fruits, fresh vegetables, and seafood have the greatest percentage of imports at 55%, 32%, and 94%, respectively.

Donald-Prater-900x900.pngImportantly, the FDA’s public health mandate does not distinguish between foods produced in the U.S. and those produced in other nations. We require all food that reaches U.S. consumers to meet the same safety standards.

That said, there are unique challenges associated with the oversight of imported food. Global food supply chains are complex, with varying food safety systems and differing regulatory oversight among the more than 200 countries and territories exporting food to the U.S.

 


Guidance Documents

Procedures for Handling Post-Approval Studies Imposed by PMA Order

The purpose of this guidance document is to assist stakeholders with understanding post approval study (PAS) requirements imposed as a condition of PMA approval. The final guidance “Procedures for Handling Post-Approval Studies Imposed by PMA Order” is intended to update and replace the guidance issued in June 2009.


Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and accuracy in dosing.


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.


Webinars and Virtual Workshops

Challenges and Opportunities for REMS Integration, Innovation, and Modernization

October 11, 2022; 1:00 PM - 5:15 PM ET

The FDA and Duke-Margolis are collaborating to host a virtual public workshop to solicit feedback from key stakeholders on a Risk Evaluation and Mitigation Strategies (REMS) integration prototype.


FDA Oncology Center of Excellence Conversations on Cancer: Highlights in Oncofertility: Trends in an Emerging Field for Cancer Survivors

October 12, 2022; 2:00 PM - 3:00 PM ET

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The field is largely focused on medical and surgical methods to achieve preservation and restoration of reproductive function and hormonal balance in patients diagnosed with cancer. It also engages the psychosocial aspects of infertility from cancer and treatment through counseling and education.

The goal of oncofertility programs is to achieve fertility in as many patients desiring biological offspring as possible and to reduce altered hormonal function in all patients.


Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins

October 13, 2022; 12:00 PM - 1:00 PM ET

Learning Objectives

  1. Discuss how the LC-MS based multi-attribute method can be used for quality control of therapeutic proteins.
  2. Discuss how the multi-attribute method can detect multiple product quality attributes or critical quality attributes within a single LC-MS run.
  3. Discuss the key considerations for implementation of the multi-attribute method, including risk assessment, method validation, new peak detection, and conventional method comparisons.

Webinar - Clinical Decision Support Software Final Guidance

October 18, 2022; 1:00 PM - 2:15 PM ET

FDA will host a webinar for industry and interested stakeholders to discuss and answer questions about the Clinical Decision Support Software final guidance.

Registration is not necessary.


12th Annual Global Summit on Regulatory Science

October 19 - 21, 2022

The 12th annual Global Summit on Regulatory Science (GSRS22) will be held October 19 - 21, 2022, in Singapore. It is being co-hosted by Singapore Food Agency (SFA) and the Global Coalition of Regulatory Science and Research (GCRSR). The theme for this year’s Global Summit is “Advances in Nanotechnology for Food and Medical Products: Innovations, Safety, and Standards.”


Webinar on the Proposed Changes to the Definition of “Healthy”

October 21, 2022; 1:00 PM - 1:45 PM

The FDA will host a stakeholder webinar to provide an overview of the recently released proposed rule to update the definition of the nutrient content claim “healthy.” The “healthy” claim can act as a quick signal on food package labels to help empower consumers with information to identify foods that will help them build healthy eating patterns. This action is just one part of the agency’s ongoing commitment to reduce diet-related chronic diseases and advance health equity.


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.

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