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Product Approvability Recommendations From FDA Advisory Committees:: Inconsistently Sought, Indirectly Obtained.

07:00 EST 1st January 2018 | BioPortfolio

Summary of "Product Approvability Recommendations From FDA Advisory Committees:: Inconsistently Sought, Indirectly Obtained."

Divisions within the Food and Drug Administration (FDA) often convene meetings of advisory committees, also known as AdComm or Panel meetings. The purpose of many AdComm meetings is for the FDA to obtain outside advice and recommendations on whether to approve a new drug or medical device. Laws and regulations indicate that such Panels are to provide recommendations regarding the approvability of the drug or device by FDA.

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This article was published in the following journal.

Name: Therapeutic innovation & regulatory science
ISSN: 2168-4804
Pages: 2168479018764654

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Medical and Biotech [MESH] Definitions

Groups set up to advise governmental bodies, societies, or other institutions on policy. (Bioethics Thesaurus)

Committees established by professional societies, health facilities, or other institutions to consider decisions that have bioethical implications. The role of these committees may include consultation, education, mediation, and/or review of policies and practices. Committees that consider the ethical dimensions of patient care are ETHICS COMMITTEES, CLINICAL; committees established to protect the welfare of research subjects are ETHICS COMMITTEES, RESEARCH.

Committees of professional personnel who have responsibility for determining policies, procedures, and controls related to professional matters in health facilities.

Hospital or other institutional ethics committees established to consider the ethical dimensions of patient care. Distinguish from ETHICS COMMITTEES, RESEARCH, which are established to monitor the welfare of patients or healthy volunteers participating in research studies.

Form in which product is processed or wrapped and labeled. PRODUCT LABELING is also available.

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