Search Results for keywords:"clinical trials"

The National Center for Complementary and Integrative Health is hosting a meeting on April 11th and 14th, 2025, to evaluate grant applications for clinical trials of complementary and integrative interventions. This meeting will be closed to the public to protect confidential information and personal privacy. It will be conducted as a video-assisted meeting, and the address provided is in Bethesda, Maryland. The event is being organized under the Federal Advisory Committee Act.

The Food and Drug Administration (FDA) has reorganized its Center for Drug Evaluation and Research (CDER), specifically within the Office of Medical Policy (OMP), which was approved by the Secretary of Health and Human Services on November 19, 2024. This reorganization aims to improve the FDA's ability to conduct its public health mission by enhancing its capacity to innovate in clinical trials, using tools such as Artificial Intelligence (AI) and Digital Health Technologies (DHTs). The Division of Clinical Trial Quality has been renamed to the Division of Clinical Innovations to support this focus. This restructuring is intended to foster collaboration, attract a diverse workforce, and modernize policy development to guide innovative drug development practices.

Myonex Inc has applied for registration as an importer of specific controlled substances, according to a notice from the Drug Enforcement Administration (DEA). The substances are intended for use in clinical trials, research, and analytical purposes, and not for commercial sale of finished dosage forms. Interested parties have until March 29, 2021, to submit written comments or objections, or to request a hearing regarding this application. Written submissions should be directed to the DEA at their office in Springfield, Virginia.

The National Institutes of Health is holding a meeting on January 30, 2025, from 10:00 a.m. to 5:00 p.m. to review and evaluate grant applications for clinical trials related to remote complementary and integrative interventions. The meeting is closed to the public to protect sensitive personal, commercial, and patent-related information. It will be conducted virtually, and the contact person for more information is Dr. Marta V. Hamity.

The National Heart, Lung, and Blood Institute announced several upcoming closed meetings to review and evaluate grant applications, related to various medical research projects. These meetings will take place virtually on different dates in March 2021 and will focus on topics like regenerative medicine, clinical trials, and mentored career development awards. The meetings are closed to the public to protect confidential information and personal privacy, as required by law. Specific contact persons are provided for each meeting, ensuring interested parties can reach out for more information.

Myonex LLC has submitted an application to the Drug Enforcement Administration (DEA) to become a registered importer of certain controlled substances. The company plans to import these substances in dosage forms specifically for use in clinical trials, research, and analytical work, but not for commercial sales. Interested parties, including manufacturers or other applicants, are invited to submit comments or objections to this application by May 19, 2025, and they also have the option to request a hearing. No commercial activities involving the finished dosage forms are allowed under this registration.

Catalent Pharma Solutions, LLC has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company plans to import these substances in finished dosage forms for clinical trials, research, and analytical activities. Comments or objections regarding this application can be submitted electronically by March 28, 2025. Any hearing requests should be sent to the DEA at their Springfield, Virginia address.

Pharmaron Manufacturing Services (US), LLC has applied to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of certain controlled substances. This registration is intended to allow the company to produce materials for clinical trials. Interested parties can submit comments or request a hearing on the application by May 27, 2025, via the Federal eRulemaking Portal. The application was officially filed on February 11, 2025, and no other activities related to these substances are authorized beyond clinical trial production.

Purisys, LLC has applied to become a registered bulk manufacturer of certain controlled substances, as announced by the Drug Enforcement Administration (DEA) under the Justice Department. The company intends to produce these substances for use as active pharmaceutical ingredients and analytical reference standards, and to support clinical trials. People or companies who are already registered bulk manufacturers or applicants of these substances may submit comments or request a hearing on the application by April 21, 2025. Comments must be submitted electronically via the Federal eRulemaking Portal.

The National Institute on Deafness and Other Communication Disorders announced a closed meeting for the Special Emphasis Panel focusing on clinical trials and hearing disorders. The meeting is scheduled for January 15, 2025, from 2:30 p.m. to 4:30 p.m. and will be held virtually. The purpose of the meeting is to review and evaluate cooperative agreement applications, and it is closed to the public to protect confidential information. Individuals involved with the meeting include scientific review officers, and notice was filed with the Federal Register on December 18, 2024.