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.
The purpose of this guidance is to help sponsors in the development of anti-rabies virus monoclonal antibody (mAb) cocktails as an alternative to anti-rabies virus immunoglobulin (RIG) as the passive immunization component of post-exposure prophylaxis (PEP) for the prevention of rabies when given immediately after contact with a rabid or possibly rabid animal. This draft guidance is intended to serve as a focus for continued discussions among the Division of Antivirals, sponsors, the academic community, and the public.
Hyperbaric oxygen therapy (HBOT) is well known for treating scuba and deep-sea divers affected by the rapid change in pressure around them. But did you know that HBOT is also used to treat a variety of other health problems, including carbon monoxide poisoning and diabetic foot ulcers?
If you are considering the use of a HBOT device for yourself or a loved one, be aware that some claims of what it can do are unproven. For example, HBOT devices are not proven to cure cancer, Lyme disease, autism or Alzheimer's disease. The U.S. Food and Drug Administration recommends you check with your health care provider before using a HBOT device to make sure you are pursuing the most appropriate care. If your health care provider recommends HBOT, the FDA advises that you go to a hospital or facility that has been inspected and is properly accredited by the Undersea and Hyperbaric Medical Society.
Biosimilar and Interchangeable Biologics: More Treatment Choices
The U.S. Food and Drug Administration has approved biosimilar medications to treat conditions such as cancer, diabetes, Crohn's disease, colitis, rheumatoid arthritis, psoriasis, and more.
But what are biosimilar and interchangeable biosimilar biological medications? To answer that question, it helps to first know what biological products (biologics) are.
Biologics: Medications from Living Organisms
Biologics include medicines that generally come from living organisms, which can include animal cells and microorganisms, such as yeast and bacteria. That makes biologics different from conventional medications, which are commonly made from chemicals.
FDA Seeks Patient Insight: Call for Applications for the Patient Engagement Collaborative
By: Andrea C. Furia-Helms, M.P.H., Director of Patient Affairs, Office of Clinical Policy and Programs
Patients are at the heart of the U.S. Food Drug Administration's mission. Understanding patients' experiences is critical to support medic al product regulation and help ensure safe, effective and innovative medical products are available. Learning from patients helps the agency uphold its public health mission.
Today, the FDA announced the call for applications for the next cohort of the Patient Engagement Collaborative (PEC). The PEC, established in 2018 in collaboration with the Clinical Trials Transformation Initiative (CTTI), is a group of patient organizations and individual representatives who discuss ways to enhance patient engagement. CTTI and the FDA collaborate to involve representatives with a variety of perspectives including patients, caregivers and representatives from diverse patient organizations. The PEC is run by the FDA's Patient Affairs staff, which is dedicated to providing an inviting, welcoming and meaningful experience for patient communities to engage with the FDA.
The purpose of this workshop is to discuss the scientific principles and practical considerations that inform current FDA thinking and USP recommendations for IVRT and IVPT studies, explore challenging issues that would benefit from broader discussion, identify areas that would benefit from further research, and discuss opportunities for coordination and collaboration between the FDA, USP, academic institutions, product manufacturers, diffusion cell equipment manufacturers, contract research organizations, consultants, and other stakeholders.
The FDA Oncology Center of Center of Excellence presents Conversations on Cancer - Finding Calm in the Storm: Moving Toward Physical and Emotional Wellbeing. Join this 1 ½ hour informal panel discussion exploring personal perspectives from survivors, clinicians, caregivers, and behavioral health experts on the impact of cancer.
Attendees for this webinar will hear the latest updates from FDA's Center for Drug Evaluation Research (CDER) regarding policy and approaches toward manufacturing, supply chain, and inspections during the COVID19 Public Health Emergency (PHE).
The purpose and benefits of grouped submissions in eCTD format to the Office of Prescription Drug Promotion (OPDP), the content and structure of grouped submissions to OPDP in eCTD format, common errors associated with grouped submissions and how to avoid them.
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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Very informative blog... HBOT is one of the best therapy for autism patient. Shai Efrati explain the benefits of hyperbaric oxygen therapy for Autism and how it actually work. Thanks
Very informative blog... HBOT is one of the best therapy for autism patient. Shai Efrati explain the benefits of hyperbaric oxygen therapy for Autism and how it actually work. Thanks
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