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 18, 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.


Consumer Updates

How AEDs in Public Places Can Restart Hearts

AED-CU-graphic-1600x900 (1).png

Sudden cardiac arrest occurs when the heart suddenly and unexpectedly stops pumping blood. It can happen to anyone, at any time, and signs include sudden collapse and immediate loss of consciousness.

Unlike heart attacks, which are caused by a blockage in an artery to the heart, sudden cardiac arrest is caused when the heart’s electrical system malfunctions. This produces abnormal heart rhythms, called arrhythmias, that make the heart unable to pump blood.

If cardiac arrest does occur, rapid treatment with a medical device called an automated external defibrillator (AED) can be lifesaving.

Read More

How to Buy Medicines Safely From an Online Pharmacy


Have you ever been tempted to buy your medicines from an online pharmacy or another website?

You can protect yourself and your family by being cautious when buying medicine online. Some pharmacy websites operate legally and offer convenience, privacy, cost savings and safeguards for purchasing medicines.

Not all websites are the same. The FDA warns that there are many unsafe online pharmacies that claim to sell prescription drugs at deeply discounted prices, often without requiring a prescription. These internet-based pharmacies often sell unapproved, counterfeit or otherwise unsafe medicines outside the safeguards followed by licensed pharmacies.

Read More

FDA Voices

FDA’s Cybersecurity Modernization Action Plan

CMAP Voices

By: Vid Desai, Chief Information Officer (pictured below) and Craig Taylor, Chief Information Security Officer

The FDA is critical to protecting and promoting public health. The products the FDA regulates are in every supermarket, pharmacy, and home across the U.S. Cybersecurity touches every facet of the FDA’s broad, complex responsibility. It’s one of our agency’s top priorities, and we take it seriously, particularly given today’s increased cybersecurity risks.


During the pandemic, the FDA experienced a 457% increase in reconnaissance activities, denial of service, attempted exploitation, and other cyber incidents against IT infrastructure, that includes nearly 9.5 billion firewall and intrusion detection blocks on a monthly basis.

Read More

Focusing on Prevention to Safeguard Infant Formula

Infant Formula_Voices

By: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Nutrition (pictured below)

Over this last year, some families around our country faced challenges finding infant formula, a product that serves as the sole source of nutrition for many infants in the U.S. What started with reports of illnesses in infants led to a for-cause inspection of a major formula manufacturing facility.

Mayne Headshot.jpg

Environmental sampling in that facility by the FDA identified multiple strains of Cronobacter sakazakii, a potentially harmful bacteria to infants, and other insanitary conditions that prompted a large-scale voluntary recall and pause in production to safeguard public health. These actions further stressed the infant formula supply chain already strained by the COVID-19 pandemic, creating hardships for parents and caregivers who rely on these products to feed their babies and loved ones.

Recently, the FDA released an Evaluation of the Agency’s Infant Formula Response, which notes various opportunities for improvement, but at the heart of this particular issue is safety.

Read More


FDA Approves Second Interchangeable Insulin Product, Rezvoglar


The FDA approved the second interchangeable biosimilar insulin product to Lantus (insulin glargine), Eli Lilly’s Rezvoglar (insulin glargine-aglr).

Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

FDA previously approved Rezvoglar as a biosimilar to Lantus on December 17, 2021. A biosimilar is a biological product (biologic) that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic, called a reference product.

An interchangeable biosimilar is a biosimilar that meets additional requirements and may be substituted for the reference product at the pharmacy, depending on state pharmacy laws, similar to how generic drugs are substituted. A company has to specifically apply for interchangeability.

For more information about biosimilar products, visit the link below.


Webinars and Virtual Workshops

Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions

November 30, 2022; 8:00 AM - 4:30 PM ET

This conference is designed to cover two topics. First is to discuss the two Drug Master File (DMF) enhancements specified under the Generic Drug User Fee Amendments (GDUFA) III Commitment Letter which includes DMF review prior to ANDA submission and assessment of solicited DMF amendments outside of an application. Second is an update on the future state of DMF submissions and assessments including discussion of Knowledge-Aided Assessment and Structured Application (KASA), Structure-Data (SD) files and Global Substance Registration Systems (GSRS) database.

Register Here

2022 FDA Digital Transformation Symposium

32980_FDA_ODT Symposium_2022_Banner1_1143x485px_v01.png

December 5 - 7, 2022

Day 1: ET
Day 2: ET
Day 3: 8ET

About the Symposium:

  • Learn more about the FDA’s IT vision and strategic direction.

  • Hear from FDA leaders on how the agency is leveraging advances in data, cloud, user experience (UX), cybersecurity, IT governance, and operational/organizational excellence to deliver on its mission to protect public health.

  • Participate and engage in information sharing with industry, tech, and vendor communities on how the FDA can continue to collaborate with stakeholder constituents to drive innovation, key initiatives, and achieve successful technology solutions.

Register Here

Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned Webinar

December 6, 2022; 8:00 AM - 5:00 PM ET

The goal of this webinar is to provide an overview of the regulatory framework, scientific concepts, product-specific challenges, and best practices related to development of complex generic drug products that are either required or recommended to have the same formulation as their respective RLDs.

The one-day webinar will include five sessions composed of presentations from FDA and the pharmaceutical industry followed by panel discussions to answer attendee questions.

Register Here

FDA Broad Agency Announcement Day 2022

December 6, 2022; 10:00 AM - 3:30 PM ET


FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. FDA solicits for advanced research and development proposals to support regulatory science and innovation. FDA anticipates that research and development activities awarded under this BAA will serve to advance scientific knowledge to accomplish its mission to protect and promote the health of our nation.

Register Here

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.