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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
- 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
- SDTM (section Special-purpose domains)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
- 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
- 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
- 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
- to duplicate the protocol requirements used in the studies supporting its approval.” ECF No. 28 at 32. “The [FFDCA] thus requires FDA to apply its scientific
- States, it is not licensed for use in Canada. According to the FDA-approved protocol, 600 mg of mifepristone is taken orally within 49 days after the
- humanity may move forward. Northfield Reaches Agreement With FDA on Special Protocol Assessment For Pivotal Phase III Trial, PR Newswire Association, 2003