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  • FDA
    )
    somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.) The FDA's Office of Prescription Drug Promotion (OPDP)...
    116 KB (11,587 words) - 05:11, 27 March 2024
  • children in clinical trials EudraCT European Medicines Agency FDA Special Protocol Assessment International Clinical Trials Registry Platform Investigational...
    19 KB (1,865 words) - 18:50, 13 December 2023
  • unmeasured variable. The trial was conducted pursuant to a FDA Special Protocol Assessment (SPA), a set of guidelines binding trial investigators to specific...
    16 KB (1,405 words) - 17:07, 25 November 2023
  • Thumbnail for AquAdvantage salmon
    antibiotic use. On 25 December 2012, the FDA published a draft environmental assessment for AquAdvantage salmon. The FDA also published a preliminary Finding...
    24 KB (2,325 words) - 16:10, 9 February 2024
  • Thumbnail for NeuVax
    identifier NCT01479244). This study is taking place under an FDA Special Protocol Assessment. NeuVax works by harnessing the patient's own immune system...
    6 KB (585 words) - 05:49, 29 November 2023
  • regulatory authority such as the United States Food and Drug Administration (FDA). The Submission Data Standards team of Clinical Data Interchange Standards...
    14 KB (1,897 words) - 05:39, 15 September 2023
  • Administration (FDA) regulates food safety through risk assessment, while the EFSA does the same in EU. An occupational risk assessment is an evaluation...
    70 KB (8,721 words) - 11:20, 5 March 2024
  • melanoma. MVax is a cancer vaccine that received a Special Protocol Assessment agreement with the FDA in October 2006, and subsequently began a Phase III...
    6 KB (462 words) - 21:57, 18 March 2024
  • FDA Amendments Act)
    formulation cannot be developed. It also authorizes the FDA to require submission of a pediatric assessment if the Secretary finds that adequate pediatric labeling...
    21 KB (2,877 words) - 09:24, 8 April 2022
  • Thumbnail for Ridaforolimus
    response to chemotherapy. Oral ridaforolimus was granted a Special Protocol Assessment (SPA) by the FDA for the SUCCEED trial. Based on 552 progression-free...
    8 KB (680 words) - 22:27, 10 February 2024
  • a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application (NLM) Arm Any of the treatment...
    78 KB (11,553 words) - 14:26, 27 October 2023
  • National Cancer Institute and has received Fast Track and a Special Protocol Assessment from the Food and Drug Administration for its use of melphalan...
    5 KB (366 words) - 00:59, 20 August 2023
  • substance use dependence, and more. The US Food and Drug Administration (FDA) first approved the use of intranasal esketamine (Spravato)—an enantiomer...
    21 KB (2,365 words) - 16:20, 17 March 2024
  • to follow investigation protocol (the procedures and treatment subjects must undergo, as well as the schedule of assessments) Failure to keep adequate...
    7 KB (808 words) - 01:54, 9 December 2023
  • Thumbnail for Cosmetology
    cosmetology chemicals. In the United States the Food and Drug Administration (FDA) is responsible for public safety regarding cosmetic products and the Food...
    35 KB (4,219 words) - 11:24, 7 March 2024
  • Thumbnail for Sunscreen
    being five stars. In August 2007, the FDA put out for consultation the proposal that a version of this protocol be used to inform users of American product...
    120 KB (11,980 words) - 17:10, 20 March 2024
  • Thumbnail for Oxandrolone
    Kingdom. "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved...
    47 KB (4,450 words) - 11:41, 25 March 2024
  • Thumbnail for Tetrabenazine
    1999). "Tetrabenazine treatment for tardive dyskinesia: assessment by randomized videotape protocol". American Journal of Psychiatry. 156 (8): 1279–81. doi:10...
    13 KB (1,051 words) - 08:48, 16 August 2023
  • possess a satisfactory security protocol to prevent potential hackers from gaining access to these devices. The FDA recommended that health care providers...
    20 KB (1,991 words) - 23:29, 14 March 2024
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