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

May 12, 2023

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.



Consumer Updates

Have You Given Blood Lately?


Every day, hospitals throughout the U.S. transfuse blood or blood components, such as platelets, to save the lives of people who are in motor vehicle accidents, and victims of fires and other emergencies.

Blood is also required for many people with life-threatening illnesses and others undergoing routine surgeries. According to the Centers for Disease Control (CDC), blood centers and hospitals in the U.S. collect and transfuse millions of units of blood each year.


What to Ask Your Doctor Before Taking Opioids

What to Ask Your Doctor Before Taking Opioids

Every patient should ask questions when getting a new prescription. This is especially important when your doctor, dentist or other health care professional prescribes you an opioid pain medicine, such as hydrocodone, oxycodone or morphine.

Opioid medicines approved by the FDA can be used to treat certain kinds of acute and chronic pain. They also can have very serious side effects.

What should you ask your health care professional?


FDA Voices

Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies

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By: Robert M. Califf, M.D., Commissioner of Food and Drugs and Hilary Marston, M.D., M.P.H., Chief Medical Officer

The U.S. Department of Health and Human Services is planning for the federal Public Health Emergency for COVID-19 declared under the Public Health Service Act to expire on May 11, 2023. We’ve arrived at this point because of the U.S. government’s historic investments and our collective efforts to mitigate COVID-19’s worst impacts. While the HHS public health emergency is ending, COVID-19 remains a high priority and the FDA will remain engaged with numerous activities to protect and promote public health.

And while the virus is still with us, causing illness and death in some cases, the good news is we now have more tools to help protect many in our families and communities from the most harmful impacts of COVID-19.


FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing


By: Patrizia Cavazzoni, M.D., Director of the Center for Drug Evaluation and Research

Artificial intelligence (AI) and machine learning (ML) are no longer futuristic concepts; they are now part of how we live and work. The FDA uses the term AI to describe a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as learning, making decisions, and making predictions. ML is a subset of AI that uses data and algorithms, without being explicitly programmed, to imitate how humans learn.

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AI/ML’s growth in data volume and complexity, combined with cutting-edge computing power and methodological advancements, have the potential to transform how stakeholders develop, manufacture, use, and evaluate therapies. Ultimately, AI/ML can help bring safe, effective, and high-quality treatments to patients faster.



Guidance Documents

Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components

This guidance recognizes, as acceptable, the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 4.0 dated May 2023, prepared by the AABB Donor History Task Force.

Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

We, FDA, are issuing this guidance to provide recommendations for evaluating donor eligibility using individual risk-based questions. This guidance provides you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection.

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.


Hearing Aids and Personal Sound Amplification Products: What to Know


Are you or a loved one having a hard time hearing? Perhaps you considered getting a hearing aid in the past?

Hearing aid technology keeps evolving, which means there’s a growing variety of styles and features to consider.

“People who already use a hearing aid know that selecting one is not a simple decision,” says Eric Mann, M.D., Ph.D., Senior Advisor in the FDA office responsible for hearing aids. “Hearing loss affects people in different ways. So, it’s important to choose a hearing aid that’s appropriate for your condition and fits your lifestyle.”


Webinars and Virtual Workshops

Webinar Series to Discuss Infant Formula Food Ingredients and Packaging Requirements

May 24, 2023; 2:00 PM - 3:00 PM ET

The FDA will host webinars to provide stakeholders with information on regulatory requirements and considerations for infant formula ingredients and packaging.

The FDA plays a critical role in ensuring the safety and nutritional adequacy of infant formula in the United States. The FDA also works to ensure that infant formula sold in the United States meets the required safety and nutritional standards specified in section 412 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and in the FDA’s implementing regulations at 21 CFR parts 106 and 107.


RDEA Pilot Program 2023 Public Workshop

June 7 - 8, 2023; 1:00 PM - 5:00 PM ET

As announced in the Federal Register notice published on October 27, 2022, FDA is establishing a Rare Disease Endpoint Advancement (RDEA) Pilot Program to support novel endpoint efficacy development for drugs that treat rare diseases. The RDEA Pilot Program fulfills a commitment under PDUFA VII.

Academic investigators, pharmaceutical and biotechnology companies, patient advocacy organizations, and anyone interested in developing rigorous endpoints for rare disease drug development are encouraged to attend.


2023 FDA Science Forum

June 13 - 14, 2023

Day 1: 9:00 AM - 3:30 PM ET
Day 2: 9:00 AM - 2:00 PM ET

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The Forum offers an exciting opportunity for the public to view the unique scientific research and collaborative efforts of FDA’s 11,000 scientists. You'll get a chance to see first-hand how FDA's researchers are using novel science and technologies to inform FDA’s regulatory decision-making — and drive innovation.

FDA’s Science Forum welcomes the public, industry, academia, patient advocates, sister agencies, and current and potential collaborators to join us virtually and learn about the critical contributions that FDA's regulatory science makes to product quality and safety.

Visit webpage for registration options

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.