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The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.”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 The FDA is inviting the public to comment on this draft guidance by March 10, 2025, as part of their ongoing approval process requirements.

Lonza Tampa, LLC has applied to the Drug Enforcement Administration to become registered as an importer of controlled substances, specifically focusing on the drug code 7437 (Psilocybin). They plan to use Psilocybin as a bulk active pharmaceutical ingredient for clinical trials, research, and analytical purposes. The DEA is allowing registered bulk manufacturers or applicants to submit electronic comments or objections to this application by March 20, 2025. Requests for a hearing can also be submitted by this date.

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.

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 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 (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.

Sharp Clinical Services, LLC has submitted an application to register as an importer of certain controlled substances. The purpose of this registration is to import these substances for distribution and clinical trials, but not for commercial sales of finished products. The public can submit comments or objections electronically until March 28, 2025, and requests for a hearing on the application must be sent to the Drug Enforcement Administration by the same date.

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 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.