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.
Recognition of Marian Finkel OOPD's 1st Director Marion J. Finkel was born in New York City and received her medical education at the Chicago Medical School, where she earned her M. D. in 1952. After a residency in Internal Medicine that included two years at Bellevue Hospital in New York, she had a private practice and worked for the pharmaceutical industry.
FDA hired Dr. Finkel as a medical officer in 1963, as the agency began implementing the most significant shift in drug regulation since 1938, the Drug Amendments of 1962, and she moved into increasingly important administrative positions in drug management.
By 1968 she was Director of the Division of Metabolic and Endocrine Drugs, one of six divisions in the Office of New Drugs.
Emergency use authorization (EUA) allows these vaccines to be distributed in the U.S. Learn more about EUAs for COVID-19 vaccines from the FDA's Center for Biologics Evaluation and Research (CBER).
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).
Here are some ways you and your family can help slow the spread of coronavirus disease.
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.
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.
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.
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
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.
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.
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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