FDA Stakeholder Update – April 30, 2021

April 30, 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 April 30, 2021 - FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose April 29, 2021 - FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers April 28, 2021 - FDA Updates Authorized Serology Test Performance April 28, 2021 - FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov April 27, 2021 - Coronavirus (COVID-19) Update April 23, 2021 - FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review April 23, 2021 - Coronavirus (COVID-19) Update April 23, 2021 - FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients Consumer Updates Safely Using Hand Sanitizer   Some hand sanitizers have potentially toxic types of alcohol. Check FDA's do-not-use list at www.fda.gov/handsanitizerlist to learn more. Need help now? Call 911 if the person is unconscious or has trouble breathing. Call the Poison Help Line at 1-800-222-1222 to connect to your local poison center. We can help stop the spread of COVID-19 by washing our hands regularly with soap and water for 20 seconds – especially after going to the bathroom, before eating, and after coughing, sneezing, or blowing our nose. If soap and water are not available, the Centers for Disease Control and Prevention recommend using alcohol-based hand sanitizers containing at least 60% alcohol to help you avoid getting sick and spreading germs to others. Read More Infant Formula: Safety Do's and Don'ts   The FDA oversees manufacturers of infant formulas and helps ensure that these products are safe and support healthy growth in infants who consume them. Don't Make Homemade Formula The FDA advises parents and caregivers to not make or feed homemade infant formula to infants. Homemade infant formula recipes have not been evaluated by the FDA and may lack nutrients vital to an infant's growth. It is important for parents and caregivers to remember that infant formula can be the sole source of nutrition for infants and is strictly regulated by the FDA. Read More Guidance Documents Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases Guidance for Sponsor-Investigators: Draft Guidance for Sponsor-Investigators The purpose of this guidance is to describe the nonclinical information that FDA recommends to support an investigational new drug application (IND) for an antisense oligonucleotide being developed to treat a severely debilitating or life-threatening (SDLT) disease caused by a unique genetic variant where only a small number of individuals are prospectively identified (usually one or two). The investigational antisense oligonucleotide should be from a well-characterized chemical class for which there is substantial nonclinical information and clinical experience that is publicly available or to which the sponsor-investigator (hereafter referred to as sponsor) has a right of reference. Read More ICYMI! (In Case You Missed It!)   FDA and CDC Virtual Press Conference: Johnson & Johnson COVID-19 Vaccine - 4/23/2021 Join us for a joint virtual press conference with the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration to discuss the Johnson & Johnson (Janssen) COVID-19 Vaccine. Click Here to Watch Webinars and Virtual Workshops Virtual Public Meeting - Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices The FDA is announcing a virtual public meeting entitled "Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices". The purpose of this meeting is to discuss patient-generated health data (PGHD) and its potential impact across the healthcare ecosystem. May 4, 2021; 10:00 AM - 4:00 PM ET Register Here FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs FDA will provide an overview of Product-Specific Guidances (PSGs), including how they are developed and revised and their role in facilitating generic drug development and generic drug application review. FDA will also discuss ways prospective and current generic drug applicants can use PSGs, including those for complex products, to improve the efficiency of generic drug development. May 5, 2021; 9:00 AM - 12:30 PM ET Register Here Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient Advocates This workshop will bring together patients, caregivers, advocates, and other important stakeholders to discuss ways for patients and their advocates to work with FDA to help advance regenerative medicine. May 6, 2021; 11:00 AM - 3:00 PM ET Register Here May 6, 2021: Meeting of the Arthritis Advisory Committee Meeting Announcement The committee will discuss new drug application (NDA) 214487, for avacopan oral capsules, submitted by ChemoCentryx, Inc., for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis. Date: May 6, 2021; 10:00 AM - 4:15 PM ET Registration is not required Common Labeling Deficiencies and Tips for Generic Drug Applications FDA will discuss the most common labeling mistakes found in Abbreviated New Drug Applications (ANDAs) and how to avoid them and other labeling tips. FDA will also provide answers to common labeling questions asked by generic drug applicants. May 7, 2021; 1:00 PM - 2:00 PM ET Register Here FDA-ASCO Hematology and Oncology Fellows Day Workshop FDA-ASCO Hematology and Oncology Fellows Day Workshop. This workshop is intended for current hematology/oncology fellows who have completed at least one year of fellowship training in an accredited U.S. training program and are currently in good standing in their fellowship program. Application process managed by ASCO. May 7, 2021, 2:00 PM – 5:00 PM Registration is not required May 11-12, 2021: Science Advisory Board to the National Center for Toxicological Research 2021 Meeting Announcement FDA announces a forthcoming virtual public advisory committee meeting of the Science Advisory Board to the National Center for Toxicological Research. The general function of the committee is to provide advice and recommendations to the Agency on research being conducted at the National Center for Toxicological Research (NCTR). At least one portion of the meeting will be closed to the public. May 11 - 12, 2021 Day 1: Tue, May 11 9:00 AM - 6:55 PM ET Day 2: Wed, May 12 9:00 AM - 12:30 PM ET 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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