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


April 14, 2022

Dear Colleague,

As you and other public health advocates work on the front lines of the COVID-19 pandemic, 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.

As we address the challenges of the COVID-19 pandemic, 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.

Stay up to date on Coronavirus Disease 2019 (COVID-19) by visiting the Resources for Health Professionals page.


 

Updates


Guidance Documents

CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances

This guidance is intended for veterinarians, State-licensed pharmacies, and Federal facilities interested in compounding animal drugs from bulk drug substances for use in nonfood-producing animals, as antidotes in food-producing animals, or as sedatives or anesthetics in free-ranging wildlife under limited circumstances when no other medically appropriate treatment options exist.


Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials

The purpose of this guidance is to provide recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan (referred to as the “Plan”) to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the United States.


E8(R1) General Considerations for Clinical Studies

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in the most resource-efficient manner.


Spotlight

Announcing Virtual Patient Engagement Advisory Committee (PEAC) Meeting

PEAC

July 12 - 13, 2022

Day 1: July 12, 2022; 10:00 AM - 4:00 PM ET
Day 2: July 13, 2022; 10:00 AM - 2:00 PM ET

The U.S. Food and Drug Administration (FDA) is announcing an upcoming virtual meeting about Augmented Reality (AR) and Virtual Reality (VR) Medical Devices.

During this meeting, the Patient Engagement Advisory Committee (the Committee) will discuss and make recommendation on factors to consider when evaluating the benefits, risks, and uncertainty for AR/VR devices. The committee will also discuss specific challenges related to vulnerable populations (for example, pediatric or cognitively impaired) who may use this technology.

Registration is not required.


Consumer Updates

Medicines For Your Pet

Medicines for your pet

If you’ve ever had to give your cat a dose of medicine, you know that it can go sideways quickly. While no cat enjoys the process, some might be more cooperative depending on how the drug is given. For example, some cats tolerate taking pills easier than liquid, while others make the pill-giving process into a battle royale.

Thankfully, your veterinarian can ask a compounding pharmacist to change that FDA-approved pill into a liquid for your finicky feline.


ICYMI!

FDA User Fee Reauthorization: Ensuring Safe and Effective Medical Devices
Testimony of Jeffrey E. Shuren, MD, JD, Director - CDRH Offices: Office of the Center Director


Give Your Community a Boost: Combatting Misinformation Through Communication and Research

National Minority Health Month - April 2022 - Give Your Community A Boost!

By: RADM Richardae Araojo, Pharm.D., M.S., Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity

April is National Minority Health Month, and the U.S. Department of Health and Human Services selected “Give Your Community a Boost” as this year’s theme. Over the last two years, the U.S. Food and Drug Administration has worked and continues working tirelessly with our U.S. government partners, medical product manufacturers, international partners, and additional stakeholders to meet the challenges of COVID-19. Although the pandemic continues, significant strides have been made in efforts to protect the health of Americans. The FDA authorized and approved vaccines, treatments, increased available testing options such as at-home tests, and provided educational resources in a variety of languages.


Webinars and Virtual Workshops

Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027

April 19, 2022; 12:00 PM - 5:00 PM ET

The FDA is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027.MDUFA authorizes the FDA to collect fees and use them for the process for the review of device applications. The current statutory authority for MDUFA expires on September 30, 2022, and new legislation will be required for the FDA to continue collecting user fees for the medical device program in future fiscal years.


2022 FDA/DIA Oligonucleotide-based Therapeutics Conference

April 25 - 27, 2022

Day 1: ET
Day 2: ET
Day 3: 7ET

The 2022 DIA/FDA Oligonucleotide-based Therapeutics Conference is intended for a diverse group of scientists responsible for the evaluation of safety and efficacy of oligonucleotide products including interested industry, academic and government parties involved in ongoing efforts in the research and development of oligonucleotides.


Generic Drugs Forum 2022: The Current State of Generic Drugs

April 26 - 27, 2022; ET

The Generic Drugs Forum (GDF) is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum is to provide information to aid potential and current applicants by offering practical advice, presenting case studies, and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process.

This year’s theme is The Current State of Generic Drugs and presentations will focus on hot topics such as the pre-ANDA program, generic drug metrics, post-market safety, pre-approval inspections, and global generic drug affairs.


Getting the Dose Right: Optimizing Dose Selection Strategies in Oncology – An FDA-ASCO Virtual Workshop

May 3, 2022 & May 5, 2022; ET

FDA and ASCO will discuss research and clinical challenges for dose optimization and highlight strategies to improve dose optimization for anticancer agents.


FDA Workshop on the Role of Phytosterols in PNALD/IFALD

May 6, 2022; 9:30 AM - 4:30 PM ET

Parenteral nutrition-associated liver disease (PNALD)/ intestinal failure-associated liver disease (IFALD) can occur in patients who require parenteral nutrition for more than two weeks, and the incidence increases with longer duration of treatment. PNALD/IFALD can result in permanent liver injury, and sometimes results in liver transplant or death. Although PNALD/IFALD has many risk factors, the phytosterol content of intravenous lipid emulsions (ILEs) used as part of total parenteral nutrition is a modifiable risk factor. In the last six years, FDA approved ILEs with lower or no phytosterol content.


FY 2022 Generic Drug Science and Research Initiatives Public Workshop

May 9 - 10, 2022

Day 1: ET
Day 2: ET

The purpose of the public workshop is to provide an overview of the status of current science and research initiatives for generic drugs and an opportunity for public input on these initiatives. The public workshop also fulfills FDA’s commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its future GDUFA Science and Research Initiatives.


Cheminformatics Resources of U.S. Governmental Organizations

May 9 - 11, 2022; ET

The workshop, Cheminformatics resources of U.S. Governmental organizations, will bring together cheminformaticians working in different branches of the U.S. Government to share experience and challenges in creating and maintaining computational resources pertaining to structures and properties of molecules and materials.


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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