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.

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October 2, 2020

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.


Consumer Perspectives on the Covid-19 Pandemic: A Conversation with the FDA & the National Consumers League, YouTube [9/29/2020]

OC_OEA_SES_FDA Commisoner_ Stephen Hahn_NCL_Sally Greenberg


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


Updates


Guidance Documents - Request for Comment

Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry
This guidance is intended to assist sponsors in developing drugs for medication-assisted treatment of opioid use disorder (OUD). This guidance addresses the clinical endpoints acceptable to demonstrate effectiveness of such drugs.

Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry
This guidance describes recommended procedures to obtain a National Drug Code (NDC) for certain FDA-approved prescription drug products that are imported into the United States in compliance with section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381).

Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment
This guidance provides recommendations to sponsors regarding the development of drugs and biologics, regulated by CDER and CBER for the adjuvant treatment of muscle-invasive bladder cancer.

Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment
This guidance provides recommendations to sponsors regarding the development of drugs and biologics,regulated by CDER and CBER for the adjuvant treatment of renal cell carcinoma.


FDA Voices

A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response

CDRH Covid Response FDA Voices

By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs

If you want to know the U.S. Food and Drug Administration’s impact on COVID-19, look no further than the numbers. In a few short months, the agency’s Center for Devices and Radiological Health’s (CDRH) response to the pandemic has been unprecedented in terms of volume, speed, and agility – spanning multiple areas, including: regulatory flexibility, Emergency Use Authorizations (EUAs) for devices, shortage mitigation activities, Public Health Service Corps deployment, and extensive engagement with stakeholders. Additionally, over 50 percent of CDRH employees have dedicated an incredible number of hours to the COVID-19 response, in addition to performing their existing responsibilities at the FDA.

Commisioner Dr. HahnAs we grapple with COVID-19, the echoes of the 1918 pandemic ring loud and clear. Although that virus infected more than 500 million people – or one-third of the world’s population – and killed 675,000 Americans, modern day travel has made the potential of this pandemic very concerning. As we grapple with COVID-19, the echoes of the 1918 pandemic ring loud and clear. Although that virus infected more than 500 million people – or one-third of the world’s population – and killed 675,000 Americans, modern day travel has made the potential of this pandemic very concerning. [9/29/2020]


Consumer Updates

It’s a Good Time to Get Your Flu Vaccine

Get Flu Vaccine Calendar

While the United States remains focused on the COVID-19 pandemic, we need to also be aware of flu season as we approach winter. Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now 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 important protection from flu and its potential complications. [9/30/2020]


Webinars and Virtual Workshops

Public Meeting on Patient-Focused Drug Development for Stimulant Use Disorder
FDA is hosting a virtual public meeting on Patient-Focused Drug Development for Stimulant Use Disorder. This meeting will provide FDA the opportunity to obtain input from individuals who are struggling or have struggled with the use of cocaine, crystal meth, methamphetamine, or misuse of prescription stimulants such as Adderall or Ritalin. Family members, advocates, caregivers and other stakeholders are encouraged to participate and share their views on the condition.

October 6, 2020; 12:30 PM - 5:00 PM ET

Please register here.


Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Thecommittee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the TransMedics Organ Care System (OCS)--Heart, by TransMedics, Inc.

October 7, 2020; 9:00 AM - 6:00 PM ET

Registration is not required.


Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
The FDA will host a virtual Town Hall for SARS-CoV-2 test developers. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

October 7, 2020; 12:15 PM - 1:15 PM ET

Registration is not required.


Bioequivalence of Complex Topical Generics: In Vitro and In Vivo
This presentation summarizes a series of FDA-coordinated, GDUFA-funded research studies included in a strategic multi-year, multi-million dollar research program to develop new, more efficient approaches by which to evaluate bioequivalence (BE) for topical generics.

October8, 2020; 12:00 PM - 1:00 PM ET

Please register here.


About Us

The FDA Stakeholder Engagement Staff reside within the Office of the Commissioner and support the FDA mission by engaging with Patient and Health Professional Organizations, Consumer Groups, Trade Associations, Think Tanks and other external stakeholders. We encourage and support active engagement from external stakeholders related to policy that impacts human and animal medical products, cosmetics, tobacco, nutrition and food safety that promote health and healthy living.

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