The FDA and invited participants may attend the meeting in-person at the FDA White Oak Campus.
FDA and invited participants may attend the meeting in-person at the FDA White Oak campus.
Today, the FDA’s Center for Biologics Evaluation and Research (CBER) is announcing that the May 16, 2024, meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is being rescheduled to June 5, 2024.
On Monday, the FDA and the National Institutes of Health (NIH) published a request for information seeking public comments on a proposed glossary of clinical research terminology.
This glossary is intended to facilitate communication within the clinical research community, by helping establish a common vocabulary to more uniformly characterize clinical research.
The FDA and the NIH identified and developed definitions for 37 terms related to innovative clinical study designs.
On Monday, the FDA announced a webinar that will be held on Tuesday, May 14, 2024, from 1-2 p.m.
On Sunday, the FDA Oncology Center of Excellence (OCE) launched the Project 5 in 5 crowdsourcing initiative.
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May 07, 2024.
Presently, the U.S. S. The Food and Drug Administration offers the following quick overview of news from across the organization:.
The FDA today announced that the Psychopharmacologic Drugs Advisory Committee will convene on June 4 to deliberate over a new drug application that Lykos Therapeutics has filed for the treatment of post-traumatic stress disorder using midomafetamine (MDMA) capsules. The committee will talk about the product’s overall benefit-risk profile as well as any potential effects on public health.
On-site attendance at the FDA White Oak Campus is permitted for invited participants and the FDA. Zoom is a video conferencing platform that will allow the public to participate via online teleconferencing.
Eli Lilly and Company’s biologics license application for donanemab, which is intended to treat early-stage symptomatic Alzheimer’s disease, was made public today by the FDA. The meeting of the Peripheral and Central Nervous System Drugs Advisory Committee is June 10.
The meeting will be held in person at the FDA White Oak campus for invited participants and the FDA. Zoom, an online video conferencing platform, and/or online teleconferencing will be available for the general public to participate in.
This announcement is a result of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting being rescheduled from May 16, 2024, to June 5, 2024 by the FDA’s Center for Biologics Evaluation and Research (CBER). Moving the meeting to a later date will give the Committee more time to gather surveillance data and other information on recently circulating strains, ensuring that committee members will have more up-to-date information when making their recommendations. The meeting will be used to discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 Formula for COVID-19 vaccines. The agency does not believe that the date change will affect the COVID-19 vaccine supply for the fall vaccination campaign. The FDA’s top goal is to guarantee that the vaccinations accessible in the U.S. S. are best suited for use with the strain or strains of the respiratory virus that are predicted to be in circulation when the fall vaccination campaign is conducted. The new date will be added to the meeting’s website as soon as feasible.
A proposed glossary of terms used in clinical research was the subject of a request for information published on Monday by the FDA and the National Institutes of Health (NIH). The purpose of this glossary is to help create a common vocabulary that will more consistently characterize clinical research, thereby facilitating communication within the clinical research community. 37 terms pertaining to novel clinical study designs were identified and given definitions by the FDA and the NIH. For forty-five days, the public comment period will be open.
A webinar scheduled for Tuesday, May 14, 2024, from 1-2 p.m. was announced by the FDA on Monday. m. ET to talk about the recently approved “Medical Devices; Laboratory Developed Tests” (LDTs) rule. The Federal Food, Drug, and Cosmetic Act clearly defines in vitro diagnostic products (IVDs) as devices, even when the manufacturer of the IVD is a laboratory. The FDA will outline the final rule amending its regulations to make this clear during the webinar. They will also discuss the phase-out of the FDA’s general enforcement discretion approach for LDTs.
Project 5 in 5 is a crowdsourcing initiative that the FDA Oncology Center of Excellence (OCE) launched on Sunday. With this initiative, OCE hopes to give the oncology community a chance to suggest key questions that could be addressed by practical clinical trials over the course of the next five years.
For trial participants, investigators, and sponsors, traditional prospective randomized controlled trials in oncology are often associated with extensive monitoring, assessments, tests, and clinical follow-up visits. Pragmatic trials are intended to gather only the data required to address the research question, and they can be crafted to be more representative of standard clinical practice.
Project 5 in 5 is accepting submissions through July 5, 2024. To learn more about how to submit your questions and to view examples of ideas that are welcome, visit OCE’s Crowdsourcing website. Staff members of the FDA will moderate all submissions and discussions on the website.
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