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


October 14, 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

It’s a Good Time to Get Your Flu Vaccine

calendar reminder to get your flu vaccine

Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated in the fall can lower your chances of getting the flu.

Flu is a serious disease, caused by influenza viruses, that can lead to hospitalization and even death. Every flu season is different, and the substantial health impacts can vary widely from season to season, with some flu seasons being worse than others. Your best defense is vaccination, which provides protection from flu and its potential complications.


FDA Voices

FDA Seeks Feedback on Distributed and Point-of-Care Drug Manufacturing

Point-of-Care Drug Manufacturing

By: Michael Kopcha, Ph.D., R.Ph., Director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, and Manuel Osorio, Ph.D., Senior Scientist, Immediate Office of the Director, Center for Biologics Evaluation and Research

Pharmaceutical manufacturers have generally produced drugs at large fixed-location facilities, but some are now developing smaller, mobile drug manufacturing processes that can be deployed to multiple locations, including at the point of care, such as at a hospital or clinic. These novel distributed manufacturing (DM) and point-of-care (POC) manufacturing technologies have the potential to improve the reliability and robustness of the drug supply chain.


FDA Releases New, Prevention Strategies to Enhance Food Safety

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By: Mark Moorman, Ph.D., Director of the Office of Food Safety, and Stephen Hughes, M.S., Prevention Coordinator (pictured below)

Protecting consumers from foodborne illness requires both rapid response when outbreaks occur, and focused attention on preventing outbreaks from happening.

Mark MoormanOver the last decade, following enactment of the FDA’s Food Safety Modernization Act (FSMA), the FDA has investigated more outbreaks and conducted more research to advance our scientific understanding of the pathogens that contaminate our food — than any other time in history.

We now know more than ever about the reoccurrence of contributing factors that can cause contamination of certain foods by specific disease-causing bacteria and how all parts of the food safety system – which includes the FDA and other government agencies, state and local health departments, the food industry, and others – can work together to keep such contamination from happening.

 


Guidance Documents

ANDA Submissions – Prior Approval Supplements Under GDUFA

This guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). The guidance explains how the Generic Drug User Fee Amendments (GDUFA) relates to PAS submissions. The guidance revises the guidance of the same title issued in October 2017.


PDUFA VII: Assessment of FDA and Sponsor Communications Through Product Quality Information Requests

Per the PDUFA VII commitment letter, FDA is announcing an opportunity for public comment on the Statement of Work for the third-party assessment of product quality IRs and Four-Part Harmony. Following the public comment period, FDA will revise the Statement of Work as needed and request contractor proposals.

The public can access the Statement of Work here.


Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA

This final guidance is intended to assist original applicants and holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) with implementing a chemistry, manufacturing, and controls (CMC) postapproval change through the use of a comparability protocol (CP).


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 Takes Steps to Further Harmonize Clinical Research Regulations with HHS Common Rule

Human Subject Protection Regulations_Voices_FINAL_1600x900.pngClinical trials play a crucial role in advancing science and supporting the development of new medical products to address unmet patient needs. Reliable data from well-designed trials about a medical product’s safety and effectiveness are critical to the FDA's decision-making about a product’s benefits and risks.

In general, clinical trials, particularly advanced stage trials, that enroll participants reflecting the diversity of patient populations will help make it possible to apply the findings from clinical trials to broader patient populations and maximize the public health impact of FDA cleared or approved products.

 


REPLAY! Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (Monkeypox)

The FDA continues to host virtual Town Hall series for SARS-CoV-2 (COVID-19) test developers and will now also include information and answer questions about monkeypox test development.


Webinars and Virtual Workshops

Webinar - Clinical Decision Support Software Final Guidance

October 18, 2022; 1:00 PM - 2:15 PM ET

The FDA will host a webinar for industry and interested stakeholders to discuss and answer questions about the Clinical Decision Support Software final guidance.

Registration is not required.


Webinar on the Proposed Changes to the Definition of “Healthy”

October 21, 2022; 1:00 PM - 1:45 PM ET

The FDA will host a stakeholder webinar to provide an overview of the recently released proposed rule to update the definition of the nutrient content claim “healthy.” The “healthy” claim can act as a quick signal on food package labels to help empower consumers with information to identify foods that will help them build healthy eating patterns. This action is just one part of the agency’s ongoing commitment to reduce diet-related chronic diseases and advance health equity.


Webinar Series to Discuss the Infant Formula Transition Plan for Exercise of Enforcement Discretion

October 21, 2022; 2:00 PM - 3:00 PM ET

The FDA will host a 4-part webinar series to provide more in-depth information about the details outlined in the Infant Formula Transition Plan for Exercise of Enforcement Discretion and address questions.


Co-sponsored Public Workshop - Expediting Innovation of Bioelectronic Implants for Vision Restoration

October 24 - 25, 2022; 8:30 AM - 3:30 PM ET

Bioelectronic-Implants-Workshop.jpg

The purpose of this workshop is to provide a forum for all stakeholders, including patients, clinicians, manufacturers, regulators, and professional societies to share their perspectives on the safety and effectiveness of bioelectronic implants for vision restoration.


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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