Updates Guidance Documents - Request for Comments Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry FDA is issuing this guidance to describe how we will request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA's bioresearch monitoring (BIMO) program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the duration of the COVID-19 public health emergency. FDA Voices A Year Into the Pandemic: How the FDA's Center for Devices and Radiological Health is Prioritizing its Workload and Looking Ahead  By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality, CDRH The response to the COVID-19 pandemic by the medical device industry and the clinical community has been impressive. Throughout the public health emergency, staff at the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) have worked tirelessly and strategically to meet unprecedented workload demands and to help provide access to high quality, critical products that are essential in protecting the public health. We authorized a record number of novel medical devices in 2020 and have issued 10-fold more Emergency Use Authorizations (EUAs) during COVID-19 than all other previous public health emergencies combined. However, this means that we are also prioritizing and triaging our work using existing resources in order to focus on our COVID-19 response, resulting in delays in some other work areas.  By: RADM Richardae Araojo, Pharm.D., M.S., Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research Each April we celebrate National Minority Health Month and this year's theme is "Vaccine Ready." There are many questions about how we effectively diagnose, treat, and prevent COVID-19, which continues to disproportionately impact racial and ethnic minority communities, Tribal communities, and other diverse groups. Many Black and Hispanic Americans have been getting vaccinated against COVID-19 at lower rates than white Americans, but are more likely to contract COVID-19, be hospitalized, and die from the disease. ICYMI!  As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given. Webinars and Virtual Workshops 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. April 21, 2021; 12:15 PM - 1:15 PM ET No registration required. This public workshop is currently being scheduled and planned as a virtual meeting. The Food and Drug Administration, NIAID and CDC are announcing the following virtual public workshop entitled "Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea." The purpose of the public virtual workshop is to discuss the nonclinical and clinical pharmacology data and clinical trial design considerations regarding developing antimicrobial drugs for the treatment of gonorrhea. April 23, 2021; 9:00 AM - 5:00 PM ET The FDA will continue to host the webinar series Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic. Personal protective equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, surgical masks, respirators or other equipment designed to protect the wearer from injury or the spread of microorganisms. April 27, 2021; 12:00 PM - 1:00 PM ET No registration required. The committee will hear updates on certain supplemental biologics license applications (sBLAs) approved under 21 CFR 601.40 (subpart E, accelerated approval regulations) with confirmatory trial(s) that have not verified clinical benefit. These updates will provide information on: (1) the status and results of confirmatory clinical studies for a given indication; and (2) any ongoing and planned trials. Confirmatory studies are post-marketing studies to verify and describe the clinical benefit of a drug after it receives accelerated approval. Based on the updates provided, the committee will have a general discussion focused on next steps for each product including whether the indications should remain on the market while additional trial(s) are conducted. April 27 - 29, 2021; 1:00 PM - 5:30 PM ET No registration required. This event offers practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) review process. Presentations will focus on various aspects from pre-ANDA, drug development, post-marketing and global generic drug affairs program support for the generic drug program. April 28 - 29, 2021; 7:40 AM - 4:34 PM ET 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 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 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 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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