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 29, 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


ICYMI!

FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death

Califf Quote

The FDA announced proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars. These actions have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the U.S., by reducing youth experimentation and addiction, and increasing the number of smokers that quit.


Guidance Documents

Draft Guidance for Industry: Action Levels for Lead in Juice

FDA is committed to reducing lead in food to the extent feasible. FDA’s Closer to Zero action plan is a science-based, iterative approach to decreasing toxic elements (such as lead) in foods over time, including by setting action levels. This guidance provides information to industry on the action levels for lead in juice.


Consumer Updates

Bottled Water Everywhere: Keeping it Safe

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Seems like almost everyone is carrying a bottle of water these days.

The U.S. Food and Drug Administration regulates bottled water products, working to ensure that they’re safe to drink.

The FDA protects consumers of bottled water through the Federal Food, Drug, and Cosmetic Act (FD&C Act), which makes manufacturers responsible for producing safe, wholesome, and truthfully labeled food products.


Webinars and Virtual Workshops

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

May 3, 2022 & May 5, 2022; 1:00 PM - 4:45 PM ET

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


Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation

May 9, 2022; 10:00 AM - 2:30 PM ET

FDA OWH_Public Meeting

Join the discussion on how many chronic and/or pregnancy-related health conditions require the use of medication during pregnancy and lactation. However, few clinical trials enroll pregnant or lactating participants, thus, there is a lack of data on medication safety and efficacy in this population.


FY 2022 Generic Drug Science and Research Initiatives Public Workshop

May 9 - 10, 2022

Day 1: 8:00 AM - 4:30 PM ET
Day 2: 8:00 AM - 5:00 PM 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; 9:00 AM - 4:00 PM 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.


Conversations on Cancer: “A Global Dialogue on Ovarian Cancer”, Meeting Information; #ConversationsOnCancer

May 10, 2022; 2:00 PM - 3:00 PM ET

The Oncology Center of Excellence Conversations On Cancer public panel discussion series is observing World Ovarian Cancer Day. Join this 1-hour informal panel discussion exploring personal perspectives from survivors, clinicians, and patient advocates on the impact of ovarian cancer. Panelists will discuss global challenges of ovarian cancer drug development, address the importance of clinical trial participation, and discuss barriers for patients’ access to clinical trials.


The Saga of Phosphatidylinositol 3-Kinase (PI3K) Inhibitors

May 12, 2022; 12:00 PM - 1:00 PM ET

There are clinical trials showing concerns with survival in patients with CLL or lymphoma because of the serious side effects of the PI3K inhibitor drug class. Information on the PI3K inhibitor drug class will be discussed and how it impacts future PI3K inhibitors developed for patients with cancer.


FDA CDER & NIH NCATS Regulatory Fitness in Rare Disease Clinical Trials Workshop

May 16 - 17, 2022

Day 1: ET
Day 2: ET

Advances in rare diseases, particularly in the field of genetics, result in an active, highly innovative, and rapidly evolving area of science and drug development. Nonetheless, rare disease drug development represents an area of high unmet medical need. There are many challenges in rare disease drug development that are broadly recognized by the rare disease drug development community.


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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