Results 271 to 280 of about 787,943 (334)

End Points and United States Food and Drug Administration Approval of Oncology Drugs

Journal of Clinical Oncology, 2003
Purpose: To summarize the end points used by the United States Food and Drug Administration (FDA) to approve new cancer drug applications over the last 13 years. Materials and Methods: The FDA granted marketing approval to 71 oncology drug applications between January 1, 1990, and November 1, 2002.
John R, Johnson, Grant, Williams, Richard, Pazdur   +2 more
openaire   +3 more sources

The United States Food and Drug Administration

Cobert's Manual of Drug Safety and Pharmacovigilance, 2019
The Food and Drug Administration ("FDA") recently updated its position on Bisphenol A ("BPA") citing certain studies as the basis for "some concern" about the potential effects of BPA on the brain, behavior, and prostate glands of fetuses, infants and ...
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United States Food and Drug Administration Regulation of Human Cells, Tissues, and Gene Therapies

Advances in Experimental Medicine and Biology, 2023
Research and development of gene therapies and cell- or tissue-based therapies has experienced exponential growth in recent decades and the potential for these products to treat diverse, often rare, clinical indications is promising. The Office of Therapeutic Products (OTP) in the Center for Biologics Evaluation and Research (CBER) at the United States
Sandhya, Sanduja, Liz, Lessey-Morillon, Rondine, Allen, Xiaofei, Wang, Gavin, Imperato, Judith, Arcidiacono   +5 more
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Prohibited or regulated? LSD psychotherapy and the United States Food and Drug Administration

History of Psychiatry, 2016
Over the 1950s and early 1960s, the use of the hallucinogenic drug lysergic acid diethylamide (LSD) to facilitate psychotherapy was a promising field of psychiatric research in the USA. However, during the 1960s, research began to decline, before coming to a complete halt in the mid-1970s.
Matthew Oram
openaire   +3 more sources

United States Food and Drug Administration Regulation of Gene and Cell Therapies

Advances in Experimental Medicine and Biology, 2015
The United States (US) Food and Drug Administration (FDA) is a regulatory agency that has oversight for a wide range of products entering the US market, including gene and cell therapies. The regulatory approach for these products is similar to other medical products within the United States and consists of a multitiered framework of statutes ...
Alexander M, Bailey, Judith, Arcidiacono, Kimberly A, Benton, Zenobia, Taraporewala, Steve, Winitsky   +4 more
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United States food and drug administration

Clinical Engineering Handbook, 2020
C. Carey
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Incentivizing Orphan Product Development: United States Food and Drug Administration Orphan Incentive Programs

Advances in Experimental Medicine and Biology, 2017
Over 30 years ago, the United States (US) Congress passed the Orphan Drug Act (ODA) to encourage the development of products for rare diseases or conditions ("orphan products"). The Act provided incentives to sponsors for developing products with orphan designation and established a grant program to fund studies of orphan products.
Tran T Le
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Oncology drug development: United States Food and Drug Administration perspective

Critical Reviews in Oncology/Hematology, 2002
The Food and Drug Administration (FDA) in the United States has multiple roles. The primary responsibilities for oncology drug products are the supervision of clinical research, the evaluation of marketing claims for new and previously approved drugs, the granting of exclusive marketing licenses for approved claims, and the monitoring of post-marketing
Steven, Hirschfeld, Richard, Pazdur
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Drug‐Associated Acute Kidney Injury Identified in the United States Food and Drug Administration Adverse Event Reporting System Database

Pharmacotherapy, 2018
Acute kidney injury (AKI) is a common condition associated with both short‐term and long‐term consequences including dialysis, chronic kidney disease, and mortality.
H. Welch, J. Kellum, S. Kane‐Gill
semanticscholar   +1 more source