🧪NIH Notice of Closed Meeting for Grant Application Review
The National Institute of Allergy and Infectious Diseases has announced a closed meeting to review and evaluate grant applications. This meeting is part of ongoing federal efforts to advance research in allergy, immunology, and infectious diseases, and will address confidential aspects related to the applications under consideration.
Learn More💰Notice of Closed Meeting for NIH Grant Applications Review
The Department of Health and Human Services announces a closed meeting of the National Institute of Allergy and Infectious Diseases' Special Emphasis Panel. The agenda includes the review of grant applications related to clinical trial planning and implementation. Meeting proceedings are confidential to protect sensitive information related to the applications.
Learn More💰NIH Closed Meetings for Grant Applications
The Department of Health and Human Services announces closed meetings of the National Institute of Allergy and Infectious Diseases to review grant applications. These meetings, aimed at evaluating funding proposals for clinical trials and infectious disease research, emphasize the confidentiality of discussions regarding sensitive commercial information and personal data.
Learn More💊Notice of Importer Application for Controlled Substances
Sharp Clinical Services, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More🩺FDA Draft Guidance on Developing Drugs for Optical Imaging
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Developing Drugs for Optical Imaging." The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features that support development and approval of optical imaging drugs that are used in conjunction with imaging devices and intended as intraoperative aids for the detection of pathology such as tumors or to enhance the conspicuity of normal anatomical structures.
Learn More🧬FDA Guidance on Tissue Biopsies in Clinical Trials for Businesses
The Food and Drug Administration (FDA or Agency) and the Office for Human Research Protections (OHRP) are announcing the availability of a draft guidance for industry, clinical investigators, institutions, and institutional review boards (IRBs) entitled "Considerations for Including Tissue Biopsies in Clinical Trials." This guidance provides recommendations regarding considerations for tissue biopsies that may be conducted in adults and in children as part of clinical trials evaluating investigational medical products and/or that are conducted or supported by the Department of Health and Human Services (HHS).
Learn More📋FDA Guidance on Accelerated Drug Approval and Confirmatory Trials
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway." For drugs granted accelerated approval, sponsors conduct confirmatory studies that must be completed postapproval to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. This draft guidance describes FDA's interpretation of the term "underway" and discusses policies for implementing this requirement, including factors FDA intends to consider when determining whether a confirmatory trial is underway prior to accelerated approval.
Learn More⚖️FDA Guidance on Sex Differences in Clinical Evaluations Available
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Study of Sex Differences in the Clinical Evaluation of Medical Products." Clinical trials and non-interventional studies of medical products should be designed to enroll sufficient numbers of females and males to reflect the prevalence of the disease or condition for which the medical product is being investigated to help ensure the generalizability of results and facilitate exploration of potential differences in effects by sex. This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products. When finalized, this guidance will replace the guidance entitled "Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs" issued in July 1993.
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