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 28, 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

Medical Devices for Weight Loss and Weight Management: What to Know

Kyrese

Overweight and obesity are linked to a long list of health problems that includes heart disease, stroke, diabetes, and certain types of cancer.

When diet and exercise aren’t having enough of an effect, a health care professional may suggest a weight loss treatment that can include a prescription medication, bariatric surgery, or a medical device.


Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses

Kyrese

Whether your Halloween plans are for adults or kids, there’s plenty to consider before choosing a costume, putting on makeup, and eating a bag full of treats.

To help you and your loved ones enjoy a safe and happy Halloween, here are some tips from the FDA, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention.


FDA Voices

FDA Continues to Advance Medicines for Children

FDA Continues to Advance Medicines for Children

By: Dionna Green, M.D., Director, Office of Pediatric Therapeutics (pictured below), Lynne Yao, M.D., Director, Division of Pediatrics and Maternal Health, Center for Drug Evaluation and Research, and Barbara Buch, M.D., Associate Director for Medicine, Center for Biologics Evaluation and Research

Increasing the availability of safe and effective medicines for children is a key priority for the FDA. Prior to the late 1990s, very few medicines were specifically approved for use in children because of ethical concerns about including children in clinical trials.

Dionna GreeneThis resulted in doctors often using their professional judgement in recommending use of medicines approved for use in adults that had not been reviewed by the FDA for safety and effectiveness in children if he or she believed that the medicine was the best available treatment option for the child.

To address this critical public health issue, the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were enacted by Congress in 2002 and 2003, respectively, to incentivize and require pediatric studies under certain circumstances.

 


Guidance Document

Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention

The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of Clostridioides difficile infection (CDI), reduction of recurrence, or prevention of CDI.


Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions

This guidance document is intended to help FDA staff develop a request for additional information needed to make a decision on a medical device marketing application in accordance with the Least Burdensome Provisions of the Food, Drug, and Cosmetic Act (FD&C Act).


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

Formulation Characterization and Cutaneous Pharmacokinetics to Facilitate Generic Topical Product Development

November 3, 2022; 8:30 AM - 5:00 PM ET

The FDA will discuss efficient, science-based BE approaches in development that may be useful for certain prospective generic products that are compositionally different compared to the reference standard.


Webinar Series to Discuss the Infant Formula Transition Plan for Exercise of Enforcement Discretion

November 4, 2022; 2:00 PM - 3:00 PM ET

The FDA will host a 4-part webinar series to provide more in-depth information about the details outlined in the Infant Formula Transition Plan for Exercise of Enforcement Discretion and address questions.


Diagnostic and Monitoring Medical Devices for Opioid Use

November 7, 2022; 10:00 AM - 4:30 PM ET

The purpose of this workshop is to promote medical device innovation through discussions with stakeholders about important factors to inform the conduct of clinical studies for medical devices to diagnose, monitor, and manage individuals across the spectrum of opioid use, with a goal to foster the safe use of opioids.


Risk Prevention Devices of Opioid Use and Opioid Use Disorder Opportunities and Challenges

November 8, 2022; 10:00 AM - 4:00 PM ET

The purpose of this workshop is to promote medical device innovation through discussions with stakeholders about important factors to inform the conduct of clinical studies for medical devices to diagnose, monitor, and manage individuals across the spectrum of opioid use, with a goal to foster the safe use of opioids.


FDA CBER OTAT Patient-Focused Drug Development Listening Meeting - Patient Perspectives on Gene Therapy Products

November 15, 2022; 12:00 PM - 4:30 PM ET

FDA CBER OTAT PFDD Listening Meeting TW_banner_1200x628px.jpg

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual patient-focused drug development listening meeting to better understand patient perspectives on gene therapy products, including cell-mediated gene therapies. This event is being held to meet an FDA commitment that is part of the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII).


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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