Search Results for keywords:"clinical trials"

The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.” This guidance is aimed at describing how the FDA interprets the term "underway" in relation to confirmatory drug trials required after a drug has been granted accelerated approval. These trials are crucial for verifying the drug's effects on serious health conditions. The FDA is inviting the public to comment on this draft guidance by March 10, 2025, as part of their ongoing approval process requirements.

The National Institute on Aging is holding a closed meeting on April 18, 2025, to discuss and evaluate grant applications related to clinical trials for aging conditions. This meeting is closed to the public to protect confidential information, including trade secrets and personal details of individuals associated with the grant applications. It will take place virtually, and anyone interested can contact Maurizio Grimaldi, the Scientific Review Officer, for more information. The meeting notice was documented under Federal Register document number 2025-04935 and filed on March 21, 2025.

Fisher Clinical Services, Inc. has applied to the Drug Enforcement Administration (DEA) to register as an importer of certain controlled substances. The company intends to import these substances solely for clinical trials. Other types of uses or commercial sales are not allowed under this registration. Interested parties can submit comments or objections electronically by April 16, 2025, and can also request a hearing on the application by the same date.

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.

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.

Vici Health Sciences, LLC has applied to become an importer of specific controlled substances to support their research and clinical trials. The Drug Enforcement Administration (DEA) is accepting public comments and objections to this application until February 27, 2025. Interested parties can submit their comments electronically through the Federal eRulemaking Portal. The DEA has specified that this permit will not authorize the import of finished medication forms for sale.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance titled "E6(R3) Good Clinical Practice: Annex 2." This document was developed with the International Council for Harmonisation (ICH) and provides guidance for conducting clinical trials with decentralized and pragmatic elements, while using real-world data. The aim is to encourage innovative trial designs and to focus on critical aspects that affect participant safety and data reliability. Comments on the draft can be submitted until February 28, 2025, before the final version is prepared.

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 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.