Search Results for keywords:"clinical trials"

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.

The National Institute on Aging has announced a closed meeting scheduled for April 18, 2025. This meeting will take place virtually and is intended for reviewing and evaluating grant applications related to clinical trials for aging conditions. The meeting is closed to the public to protect confidential information and individual privacy. For more details, those interested can contact Dr. Maurizio Grimaldi via email.

The National Institutes of Health (NIH) is seeking approval from the Office of Management and Budget (OMB) for information collection related to the Cancer Therapy Evaluation Program (CTEP) and the Division of Cancer Prevention (DCP) under the National Cancer Institute (NCI). This information is crucial for managing clinical trials in cancer research, ensuring compliance with federal regulations, and improving processes. The request is part of the requirements of the Paperwork Reduction Act of 1995, and public comments are invited within 30 days of publication. There are no costs to respondents apart from their time, and the estimated annual burden is 151,792 hours.

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.

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.

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.

Fisher Clinical Services, Inc. has applied to the Drug Enforcement Administration to be registered as an importer of certain controlled substances. The purpose of this registration is solely for use in clinical trials, and not for the commercial sale of the substances. The public can submit comments or request a hearing about this application until April 14, 2025. Comments must be submitted electronically, and hearings can be requested in writing, with specific addresses provided for these submissions.

The Food and Drug Administration (FDA) is releasing draft guidance on studying sex differences in the clinical evaluation of medical products. This guidance aims to improve the representation of females in clinical trials and provide recommendations for analyzing sex-specific data. It highlights the importance of understanding different responses to treatments based on sex to improve safety and effectiveness. The public is encouraged to submit comments on this draft guidance by April 7, 2025.

The National Cancer Institute has scheduled a closed meeting on December 10, 2024, to evaluate requests for resources for developing new cancer treatments. The meeting is closed to protect sensitive information such as trade secrets and personal data. Due to exceptional circumstances, like the unexpected volume of project requests, the notice for this meeting was issued less than 15 days in advance. Missing this meeting could cause significant delays in cancer research funding and clinical trials.

Scottsdale Research Institute has applied to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of certain controlled substances. This registration is intended to support the production of these substances for clinical trials and research purposes. The public can submit comments or objections electronically through the Federal eRulemaking Portal by April 21, 2025. The DEA requires comments to be submitted online and will provide a tracking number to confirm submission.