| FDA Dispute Resolution Panel |
Committee, Work group, Advisory group, or Task Force |
FDA |
NIAID |
This Committee provides expertise in the evaluation of evidence submitted by pharmaceutical companies to the Food and Drug Administration (FDA) for drug approval. |
| FDA Endocrinologic and Metabolic Drug Advisory Committee |
Committee, Work group, Advisory group, or Task Force |
FDA |
NIAID |
This Committee provides expertise in the evaluation of evidence submitted by pharmaceutical companies to the Food and Drug Administration (FDA) for drug approval. |
| FDA Medical Imaging Drugs Advisory Committee |
Committee, Work group, Advisory group, or Task Force |
FDA |
CC, NCI |
The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology and makes appropriate recommendations to the Commissioner of Food and Drugs. https://www.fda.gov/advisory-committees/human-drug-advisory-committees/… |
| FDA Microbiology Devices Panel of the Medical Devices Advisory Committee |
Committee, Work group, Advisory group, or Task Force |
FDA |
NIAID |
This Committee provides expertise in the evaluation of evidence submitted by pharmaceutical companies to the Food and Drug Administration (FDA) for drug approval. |
| FDA Oncologic Advisory Committee |
Committee, Work group, Advisory group, or Task Force |
FDA |
NIAID |
This Committee provides expertise in the evaluation of evidence submitted by pharmaceutical companies to the Food and Drug Administration (FDA) for drug approval. |
| FDA Peripheral and Central Nervous System Advisory Committee |
Committee, Work group, Advisory group, or Task Force |
FDA |
NIAID |
This Committee provides expertise in the evaluation of evidence submitted by pharmaceutical companies to the Food and Drug Administration (FDA) for drug approval. |
| FDA-NCI Monthly Meeting |
Meeting/ Workshop |
FDA |
NCI |
These monthly meetings enhance communication between NCI DCTD/CTEP and FDA, thereby expediting the development of new anti-cancer agents. General topics discussed include patient safety, clinical efficacy, clinical and statistical trial design, and regulatory pathways to licensure, as well as an understanding of the operations of the sister agencies. Since NCI DCTD/CTEP acts as the official regulatory sponsor of IND studies performed in the ETCTN, and selected studies in the NCTN, PBTC, and PEP-CTN, these monthly meetings are important to ensure NCI DCTD/CTEP is performing its regulatory responsibilities in compliance with regulations and the dialogue with the FDA also helps in exploring new ways to enhance patient safety and clinical trial monitoring in a risk-based approach. New areas of discussion include the use of decentralized elements, streamlined data collection, and incorporation of real-world data components in IND studies to facilitate clinical trial conduct and ensure trial results are generalization to the patient population that suffer from the specific cancers under study in trials.The monthly meeting dates each year are discussed and scheduled in consultation with the FDA depending on the availability of appropriate FDA staff for the particular issue that will be discussed. NCI and FDA staff also have pre-meeting discussions to decide on topics that will be discussed at the monthly meetings to ensure new areas of research and design, as well as trial operational issues are incorporated into meeting agenda in a timely manner. |
| FDA-NIA collaboration on FDA's Medical Device Development Tool program |
Research Initiative |
FDA |
NIA |
The objective of this collaboration is to stimulate the participation of small businesses in the FDA's Medical Device Development Tools (MDDT) program. This collaboration led to developing a contract topic entitled DIGITIAL TECHNOLOGIES AS TOOLS TO DIAGNOSE AND MONITOR ALZHEIMER’S DISEASE (AD) AND RELATED DEMENTIAS (ADRD). This contract topic was recently approved in the May National Advisory Council on Aging meeting. The goal of this topic is to develop and demonstrate the utility of digital technologies as a measure of AD/ADRD screening and monitoring as qualified MDDTs to assess medical devices subject to regulation by FDA's Center for Devices and Radiological Health. |
| FDA-NIH Clinical Research Working Group |
Committee, Work group, Advisory group, or Task Force |
FDA |
NCI, NLM |
The use of clinical research terminology describing innovative designs and operational approaches has been inconsistent and ambiguous. Work Group activities include 1) analyzing current clinical design characteristics 2) defining a taxonomy of clinical research design characteristics 3) defining terms in acompanion glossary |
| FDA-NIH Interagency Clinical Outcome Assessments Working Group (ICOAWG) |
Committee, Work group, Advisory group, or Task Force |
FDA, FDA |
NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAMS, NICHD, NIDA, NIDCD, NIDDK, NIEHS, NIMH, NIMHD, NINDS, NLM, OD/DPCPSI, OD/DPCPSI/OBSSR, OD/DPCPSI/ODP, OD/DPCPSI/SGMRO |
The Interagency Clinical Outcome Assessments Working Group (ICOA WG) works to foster the development, evaluation, and qualification of Clinical Outcomes Assessments (COAs) for use in both medical product development and clinical research. Leveraging the unique strengths, knowledge, and resources at both the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH), the objectives of the ICOA WG are: (1) To increase communication between the relevant groups at FDA and the many separate efforts at NIH to advance measurement science by exchanging information about specific COA projects of common interest, thereby improving the knowledge base for COA development; (2) To clarify and disseminate information about the regulatory processes for evaluation of medical product development tools; (3) To foster appropriate interagency scientific efforts to generate evidence toward the development and potential qualification of novel COAs; and (4) To leverage public and private efforts toward consensus and standards development in this area. The ICOA WG is composed of representatives and selected senior staff of each agency |