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.

Catalent Greenville, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company plans to use these substances for developing bulk dosage formulations for research and clinical trials. People or organizations that have an interest in this matter can submit comments or request a hearing by March 3, 2025. Submissions can be made through the Federal eRulemaking Portal, and hearings request should be sent to the DEA at specified addresses.

The document announces several closed meetings of the Center for Scientific Review at the National Institutes of Health. These meetings, scheduled to occur between March 10 and March 16, 2021, will not be open to the public due to the confidential nature of information, such as trade secrets and personal privacy, that will be discussed. Various committees are set to review and evaluate grant applications on topics ranging from Alzheimer's Disease clinical trials to biostatistical methods, disease prevention, and drug discovery. The meetings will be conducted virtually, and the contact information for Scientific Review Officers handling these meetings is provided.

The National Institute on Aging is holding a closed meeting on April 11, 2025, to review and evaluate grant applications related to clinical trials for the management of Alzheimer's Disease. The meeting will be held virtually from 10:00 a.m. to 6:00 p.m. and is closed to the public to protect confidential information, including trade secrets and personal data. Dr. Maurizio Grimaldi is the contact person for this meeting, which will be conducted in accordance with federal laws about privacy and proprietary information.

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 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.

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.

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.

The National Institute on Aging has announced a closed virtual meeting concerning clinical trials for managing early- and late-stage Alzheimer's Disease (AD). The meeting is scheduled for April 11, 2025, and will be held from 10:00 a.m. to 5:00 p.m. It will focus on reviewing and evaluating grant applications, and the discussions may involve confidential information. The contact for the meeting is Dr. Maurizio Grimaldi, whose contact details are provided for further inquiries.

The National Institute on Aging has announced a closed meeting, set for April 9, 2025, from 1:00 p.m. to 4:00 p.m. This meeting will be conducted virtually and will focus on reviewing and evaluating grant applications related to clinical trials for aging conditions. The meeting is closed to the public to protect confidential information, such as trade secrets, patentable material, and personal data concerning individuals linked to the grant applications. For any inquiries, Dr. Maurizio Grimaldi serves as the contact person for this event.