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.
5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC
Delta-8 tetrahydrocannabinol, also known as delta-8 THC, is a psychoactive substance found in the Cannabis sativa plant, of which marijuana and hemp are two varieties. Delta-8 THC is one of over 100 cannabinoids produced naturally by the cannabis plant but is not found in significant amounts in the cannabis plant. As a result, concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD).
FDA Continues Collaboration with Drug Compounders as Second Anniversary of Compounding Quality Center of Excellence Approaches
Compounded drugs can be a critical treatment option for patients who need them; however, the U.S. Food and Drug Administration does not review these drugs for safety, effectiveness, or quality before they are marketed for patient use, and they can pose serious risks. One of the best ways to protect patients and minimize the risks presented by poor-quality compounded drugs is for the agency to work with compounders to foster higher quality products.
FDA Will Follow The Science On COVID-19 Vaccines For Young Children
As schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents are anxious about the pandemic and protecting their children. Many parents have questions about COVID-19 and when vaccines will be available for children younger than 12 years of age.
This public workshop is a forum for regulators, biopharmaceutical developers and academic researchers to discuss the current and future role of pharmacodynamic biomarkers in improving the efficiency of biosimilar product development and approval.
The University of Georgia College of Pharmacy, Institute of International Biomedical Regulatory Sciences ("UGA") and the Atlanta District of the Food and Drug Administration are co-sponsoring the 8th Annual FDA/UGA Medical Device Regulations Conference for the medical device industry and those who interact with them. September 21 - 22, 2021; 8:30 AM - 4:45 PM ET
The purpose of the public workshop is to communicate how outcomes from FDA research conducted under the Generic Drug User Fee Amendments (GDUFA) guide and facilitate generic drug development, regulatory assessment, and approval. The workshop will focus on common issues seen in Abbreviated New Drug Applications (ANDAs), link GDUFA science and research on complex products and scientific issues to product-specific guidance development and pre-ANDA meeting discussions, and examine various areas of the science and cutting-edge methodologies behind generic drug development.
September 21 - 22, 2021 Day 1: S - ET Day 2: S - ET
The FDA is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023 through 2027.
The purpose of this public workshop is to share lessons learned from the Federal COVID-19 Response or Countermeasures Acceleration Groups (formerly known as Operation Warp Speed) to bring relevant therapeutics to use in a public health emergency.
During this meeting, the Patient Engagement Advisory Committee (the Committee) will discuss factors the FDA and industry should consider to effectively communicate medical device recall information to patients and the public, including but not limited to content, format, methods used to disseminate the message, and timing of communication. The Committee will consider concerns patients have about changes to their device in response to a recall and ways patient perspectives could be incorporated in the FDA's and industry's benefit-risk decision-making of recalled medical devices.
October 6, 2021; 10:00 AM - 5:00 PM ET
Registration is not required.
About Us
The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations.
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