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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September 25, 2020

Dear Colleague,

As you and other health care providers work on the front lines of the COVID-19 pandemic, we want you to know we are here to help you and your patients through this critical time. We recognize your concerns about protecting the safety of your patients, yourselves, and your families.

While our nation’s emphasis is on combating the virus, protecting health care providers and facilitating access to critical medical supplies continue to be a top priority for the FDA.

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


Updates


FDAdeveloped newhealth education materialsthat have been culturally and linguistically tailored for diverse consumers. These materials are intended for health care professionals.

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Guidance Documents - Request for Comment

Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

This guidance provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the Pilot Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Pilot). The ASCA Pilot is described in FDA's guidance The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.

Docket Number:FDA-2019-D-3805

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency.

Docket Number: FDA-2020-D-1106


Consumer Updates

Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
While many Americans are sheltering at home to help “flatten the curve” and slow the spread of coronavirus disease (also called COVID-19), they might be tempted to buy or use questionable products that claim to help diagnose, treat, cure, and even prevent COVID-19.

Because COVID-19 has never been seen in humans before, there are currently no vaccines to prevent or drugs to treat COVID-19 approved by the U.S. Food and Drug Administration (FDA). The FDA is working with vaccine and drug manufacturers to develop new vaccines for and find drugs to treat COVID-19 as quickly as possible. Meanwhile, some people and companies are trying to profit from this pandemic by selling unproven and illegally marketed products that make false claims, such as being effective against the coronavirus. [9/21/2020]


FDA Voices

It Just Got Easier for Physicians to Help Their Patients Gain Access to Investigational Treatments

FDA CDRH COVID-19 response

By: Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner

When a patient is in need of an important medicine, paperwork and forms are the last thing their physician wants to deal with. In some cases, it’s necessary, but the U.S. Food and Drug Administration is doing everything we can to keep it to a minimum. Our expanded access program is one example.

Expanded access is a pathway for a patient with a serious or immediately life-threatening disease or condition, and no comparable or satisfactory alternative therapy, to gain access to an investigational drug or biological product (i.e., one that is still being studied for safety and effectiveness to treat that disease or condition). Many patients may be able to obtain the investigational product by participating in a clinical trial testing the drug or biologic, but expanded access helps those patients who do not qualify for a clinical trial or otherwise cannot participate. [9/23/2020]

Amy Abernethy Principal Deputy Commissioner


Equivalence: Using a Trade Mechanism to Ensure Broader Consumer Choice and Open New Markets for Molluscan Shellfish

Shellfish

By: Mark Abdoo, Associate Commissioner, Global Policy and Strategy, and Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition

For the first time, the U.S. Food and Drug Administration is using a mechanism known as equivalence to begin reopening markets in raw and processed molluscan shellfish that have been closed to trade between the United States and the European Union (EU) since 2010.

Understanding the food safety issues surrounding molluscan shellfish helps to explain the significance of the equivalence determination, and why this trade mechanism goes hand-in-hand with strong food safety protections.[9/23/2020]


FDA Insight

Join Dr. Anand Shah, FDA’s Deputy Commissioner for Medical and Scientific Affairs, and other FDA leaders as they provide their insight into issues facing the agency – including the COVID-19 pandemic and other emerging topics.

FDA Insight podcast

A Closer Look at Nutrition
Dr. Shah welcomes Dr. Susan Mayne, Director of FDA's Center for Food Safety and Applied Nutrition, to discuss nutrition and chronic disease prevention, including health disparities.


Webinars and Virtual Workshops

Public Meeting - Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond

The FDA, along with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), is announcing the following public meeting entitled "Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond" that will be held by webcast only. The purpose of the public meeting is to discuss and explore potential applications, challenges, and opportunities of using Patient Preference Information.

September 29, 2020; 10:30 AM - 4:45 PM ET

Please register here.


Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic

The FDA, along with the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA), will host a webinar on Respirators and Other PPE for Health Care Personnel Use during the COVID-19 Pandemic.During this webinar, representatives from the FDA, the CDC, and OSHA will be available to answer your questions.

September 29, 2020; 12:00PM - 1:00 PM ET

Registration is not required.


Regulatory Education for Industry: Advancing Innovative Science in Generic Drug Development Workshop

This webcastwill focus on common scientific issues seen in Abbreviated New Drug Applications (ANDAs), commonly known as generic drug applications. We will link GDUFA science and research on complex products and complex scientific issues to product-specific guidance development, discuss pre-ANDA meetings and assessment, and examine various areas of the science behind generic drug development.

September 29 - 30, 2020; 8:00 AM - 4:30 PM ET

Please register here.


Medical Devices Virtual Public Meeting - Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation

The FDA is announcing a virtual public meeting entitled "Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation". The purpose of this public meeting is to discuss the benefits and challenges of incorporating the patient perspective in regulatory decision making using patient-reported outcome (PRO) instruments.

September 30, 2020; 10:00 AM - 4:00 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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