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


November 4, 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

Use Eye Cosmetics Safely

Using Eye Makeup Safety_CU_FINAL_1600 x 900_Draft B.png

Whether you’re applying makeup every day, for a special occasion, or for a performance, it’s important to be especially careful around your eyes.

The FDA regulates all cosmetics marketed in the U.S., including mascaras, eye shadows, eye liners, concealers, and eyebrow pencils.

Most eye-area cosmetics generally have not raised safety concerns when used properly. To help you avoid the risk of infection, injury from an applicator, or use of an unapproved color additive, here are tips from the FDA’s Office of Cosmetics and Colors in the Center for Food Safety and Applied Nutrition (CFSAN).


Keep Your Dogs and Cats Safe From Holiday Hazards

Holiday_pet_safety

Happy holidays? Not if your pet gets sick. FDA’s Center for Veterinary Medicine (CVM) discusses some unhealthy holiday temptations and how to keep your animals safe.

Stocking Stuffers and Pet Treats

If your dog received a stocking full of pet treats, make sure he doesn’t gobble them all up at once, making them hard to digest. Unchewed pet treats can get stuck in the trachea (windpipe) or gastrointestinal tract (esophagus, stomach, and intestines).

If your dog is in obvious distress from eating too much too fast, contact your vet immediately. Some telltale signs are drooling, choking, or vomiting.


Guidance Documents

Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program
This guidance provides stakeholders with information regarding FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program under sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Coronavirus Aid, Relief, and Economic Security Act (or the CARES Act), which authorize FDA to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and requestors of OTC Monograph Order Requests (OMORs), other than OMORs for certain safety changes.


Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I), which went into effect on October 13, 2009. FDA received numerous questions concerning implementation of the regulatory requirements for expanded access.


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 Continues to Advance Medicines for Children

By: Dionna Green, M.D., Director, Office of Pediatric Therapeutics, 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

1000th Pediatric Labeling_1600x900.pngIncreasing 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.
This 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.

 


Webinars and Virtual Workshops

Joint Public Workshops - Medical Devices for Opioid Use

November 7 - 8, 2022

Day 1: ET
Day 2: 10:00 AM - 4:00 PM ET

The FDA is announcing two connected public workshops with the National Institutes of Health (NIH) “Diagnostic and Monitoring Medical Devices for Opioid Use” and “Risk Prediction Devices of Opioid Use and Opioid Use Disorder – Opportunities and Challenges.” The purpose of these workshops 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.

Patients, caregivers, healthcare providers and other stakeholders will share their perspectives on using opioids, living with opioid use disorder (OUD), and important features of clinical studies for novel devices designed to predict, diagnose, and monitor opioid use disorder as well as prevent overdoses.

You must register separately for each day.

 


FDA/IMS Joint Workshop: Future of Drug Development in Multiple Myeloma

November 8 - 9, 2022

Day 1: ET
Day 2: ET

The FDA and the International Myeloma Society (IMS) will host a joint symposium, to provide a forum for open discussion among academia, industry, and regulatory agencies about clinical drug development in multiple myeloma. The event will be held in person and online. This workshop will discuss trial design, patient population, and endpoints in the different multiple myeloma disease settings with an aim to advance the future of drug development.

Registration closes today, November 4, 2022 at 5:00 PM ET


FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement

November 14 - 16, 2022; 10:00 AM - 3:00 PM ET

This FDA/PQRI Workshop will bring together leaders from regulatory agencies, industry, and academia to discuss critical topics in distributed manufacturing and point of care manufacturing.


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

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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