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


May 14, 2021

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

 

Consumer Updates

Medication Errors Happen to Pets, Too

Medication Errors

 

Your dog or cat is sick, and you head to the animal hospital. The veterinarian prescribes medications that you hope will make your pet better. But with pets, as with people, medication errors can happen.


Hurricane Season: Be Prepared

It's important to safeguard your food, water, medicine and pets before, during and after any severe weather event.

Food Water Pet Medicine Emergency Preparedness

 

When gale-force winds start blowing and torrential rains raise water levels, you need to be ready.

Power outages mean refrigerated food and medicine supplies may spoil. Floods may contaminate tap water and emergency supplies not stored properly with sewage, chemicals, heavy metals, pathogenic microorganisms, or other contaminants.

If the storm or flood is severe enough, you may need to evacuate with little time to prepare. Don’t put off being prepared until the emergency hits.


ICYMI! (In Case You Missed It!)

Stakeholder Call - COVID-19 Vaccine for Adolescents

Virtual Press

Join Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., as they discuss the COVID-19 vaccine for adolescents.


Guidance Documents - Request for Comments

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex

The FDA is announcing the availability of a final guidance for industry entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance, which consists of a Guidance and Annexes, provides a framework to facilitate the management of postapproval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug products, including chemical and biotechnological/biological products. This guidance finalizes the draft guidance of the same title issued on May 31, 2018.


M9 Biopharmaceutics Classification System-Based Biowaivers

On May 11, 2021, the FDA published the guidance for industry entitled “M9 Biopharmaceutics Classification System-Based Biowaivers,” a draft of which was issued in October 2018. The guidance provides recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS)-based waiver of the in vivo bioequivalence study requirement for drug products.


Webinars and Virtual Workshops

Public Web Conference to Provide Progress Update on ICH E6 Guideline for Good Clinical Practice

The International Council for Harmonisation (ICH) members, including the FDA, the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Association, will hold a free public web conference on May 18 and 19 to provide a status update on revisions to the ICH E6 Guideline for Good Clinical Practice. This conference will consist of two similar meetings on May 18 and May 19 that will be held by the Expert Working Group (EWG) and convened by the Clinical Trials Transformation Initiative (CTTI). Individuals do not need to attend both days of the conference, although they are welcome to do so. The same topics will be presented each day with speakers from different regions to represent the global effort. All information and presentations will be provided in English.

Day 1:Tue, May 18, 2021; 8:00 AM - 11:00 AM ET

Day 2: Wed, May 19, 2021; 5:00 AM - 8:00 AM ET

Registration

To register and receive a link to the meeting, individuals should select the date that they plan to attend.

 


Potential Medication Error Risks With Investigational Drug Container Labels Public Meeting May 18-19, 2021

The Food and Drug Administration will hold the Potential Medication Error Risks With Investigational Drug Container Labels Public Meeting May 18-19, 2021. This public meeting is being convened and supported by a partnership between the Reagan-Udall Foundation and the FDA.

May 18, 2021; 1:00 PM - 4:00 PM ET

May 19, 2021; 10:00 AM - 1:00 PM ET


FDA Study Data Technical Rejection Criteria (TRC): What you need to know!

FDA is planning to implement eCTD validations in 2021 specific to submissions containing study data. FDA published the TRC to assist industry in understanding when a submission containing study will be subject to these study data eCTD validations. This webinar will provide an overview of the TRC and walk through resources currently available to help the sponsor/applicant determine if their submission is subject to these eCTD validations, creation of a simplified TS.XPT, and frequently asked questions.

May 21, 2021; 1:00 PM - 2:30 PM ET


2021 FDA Science Forum

FDA's Science Forum offers an exciting opportunity for the public to view the unique scientific research and collaborative efforts of FDA’s 11,000 scientists. You'll get a chance to see first-hand how FDA's researchers are using novel science and technologies to inform FDA’s regulatory decision-making—and drive innovation.

FDA scientific experts and nationally renowned scientists will speak on the eight topics of the 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health, highlighted below. This year’s keynote speaker is NIAID Director Anthony Fauci, M.D.

Day 1: Wed, May 26; 9:00 AM - 3:30 PM ET

Day 2: Thu, May 27; 8:55 AM - 2:00 PM ET


May 27, 2021: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

The committee will discuss the safety and efficacy of biologics license application (BLA) 761183, for teplizumab intravenous infusion, submitted by Provention Bio, Inc. The proposed indication is for the delay or prevention of clinical type 1 diabetes mellitus in at-risk (Stage 2) individuals.

May 27, 2021; 9:00 AM - 5:30 PM ET

Registration is not required.


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.

22380292641