Updates Guidance Documents - Request for Comment Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period
This guidance provides information on how you may comply with FDA's requirement to provide a unique facility identifier (UFI) recognized as acceptable by FDA when you submit your food facility registration or renewal in the Food Facility Registration Module (FFRM). Consumer Updates Traumatic Brain Injury: What to Know About Symptoms, Diagnosis, and Treatment  A car accident. A football tackle. An unfortunate fall. These things—and more—can cause head injuries. Head injuries can happen to anyone, at any age, and they can damage the brain. Here's how damage can happen: A sudden movement of the head and brain can cause the brain to bounce or twist in the skull, injuring brain cells, breaking blood vessels, and creating chemical changes. This damage is called a traumatic brain injury (TBI). The U.S. Food and Drug Administration continues to study TBI and encourages the development of medical devices to help diagnose and treat it. FDA Voices Accelerating Medical Device Innovation with Regulatory Science Tools  By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and Ed Margerrison, Ph.D., Director, Office of Science and Engineering Laboratories, CDRH Progress in science and technology offers extraordinary opportunities to develop innovative medical products that can save lives and lead to better treatments, better diagnostics and better care for patients. The U.S. Food and Drug Administration is committed to advancing the public health by helping to bring innovative technologies to market and assuring that medical devices already on the market continue to be safe and effective. ICYMI! Help Stop the Spread of Coronavirus and Protect Your Family  The COVID-19 pandemic requires that we remain vigilant in our daily lives until we can safely return to everyday activities. We can each take some simple steps to help slow the spread of coronavirus disease and protect ourselves, our families, and our communities. The steps are: - Get a COVID-19 vaccine.
- Wash your hands often with plain soap and water.
- Cover your mouth and nose with a mask when around others.
- Avoid crowds and practice social distancing (stay at least 6 feet apart from others).
Webinars and Virtual Workshops Electrical Safety in CTP Regulated Products
This presentation will discuss the reports of injuries and other adverse experiences resulting from the failures of batteries used in electronic nicotine delivery systems (ENDS; e.g., e-cigarettes) to the government agencies and news outlets from 2009-2017. April 8, 2021; 12:00 PM - 1:00 PM ET The 15th Annual FDA/DIA Biostatistics Industry and Regulator Forum 2021
This meeting is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians, and clinical trialists who develop new drugs and biologics. The workshop will appeal to statisticians in, or consulting for, the biopharmaceutical industry, clinicians, epidemiologists, drug safety professionals, regulatory and medical scientists, and other stakeholders interested in recent statistical issues in clinical research. April 14 - 16, 2021; 10:00 AM - 3:45 PM ET FDA/CDER and AASLD 2021 DILI Conference XVIII
The purpose of this scientific conference is to provide a forum for open discussion between industry, government and academia of ways in which to predict, measure, evaluate and act upon liver injury and dysfunction caused by drugs in clinical trials and in post-market treatment populations; to ensure the leading experts in industry, academia and the FDA have an opportunity to discuss current and evolving practices in the analysis of hepatotoxicity and the performance of adequate liver safety studies. April 20 & 22, 2021; 9:00 AM - 4:00 PM ET Registration is not required. Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea
This public workshop is currently being scheduled and planned as a virtual meeting. The FDA, NIAID and CDC are announcing the following public virtual 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 Generic Drugs Forum 2021: Lifecycle of a Generic Drug
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 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  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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