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.
Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1). These recommendations pertain to the format of content contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) submitted to the Center for Drug Evaluation and Research (CDER) or to the Center for Biologics Evaluation and Research (CBER).
Learn More About COVID-19 Vaccines From the FDA See the evidence for each COVID-19 vaccine and the reasoning behind the FDA's emergency use authorizations.
The U.S. Food and Drug Administration has authorized three COVID-19 vaccines for emergency use. The vaccines are:
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).
Grapefruit juice and grapefruit can be part of a healthy diet. Grapefruit has vitamin C and potassium, nutrients your body needs to work properly.
Grapefruit juice and grapefruit can affect the way your medicines work, and that food and drug interaction can be a concern. The U.S. Food and Drug Administration has required that some prescription and over-the-counter (OTC) drugs generally taken by mouth include warnings against drinking grapefruit juice or eating grapefruit while taking the drug.
FDA's Budget: Advancing the Goal of Ending the Opioid Crisis
By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs
As we confronted the COVID-19 pandemic over the past year, many of the existing public health challenges we face as a nation did not suddenly disappear. The opioid crisis in particular has remained an urgent public health priority for the U.S. Food and Drug Administration, particularly as the crisis has continued to expand, devastating families and communities across the nation.
The investments outlined in the FDA's FY 2022 budget request would address current public health needs and allow the agency to design programs intended to tackle complex challenges facing the country, such as those needed in addressing the opioid crisis, by supporting development of new therapies and smarter enforcement.
SARS-CoV-2: Host-pathogen interaction, vaccines & variants of concern Professors Carroll and Hiscox's studies reveal how the human body responds to severe SARS-CoV-2 infection which will help in future treatments of COVID-19 patients. They will also present results on the immunological response to infection and vaccination, in addition to the potential impact of new variants of the virus that are continuously evolving.
Learn directly from the FDA's regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA's regulatory requirements. View Agenda.
FDA PUBLIC WORKSHOP: 6th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop The overarching aim of this year's workshop remains the same as in past years - to provide a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the complex regulatory, health care policy, and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials. The workshop will be open to the public, fully virtual, and divided into two half-days. During the four sessions of this workshop, we will focus our discussion on regulatory-grade patient-generated data on physical function (defined as the ability to carry out day-to-day activities that require physical effort) in cancer clinical trials.
Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI) Workshop on Celiac Disease The goal of the GREAT VI workshop is to discuss the overall approach to drug development in celiac disease that includes an assessment of both clinical symptoms and histology. The workshop will focus the discussion on the histologic endpoints to assess treatment benefit in patients with celiac disease; regulatory framework for pediatric drug development in celiac disease; and the role of gluten challenge in clinical trials to provide a forum for open discussion between stakeholders to facilitate drug development.
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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