FDA Special Protocol Assessment
- FDA Special Protocol Assessment
A Special Protocol Assessment (SPA) is a declaration from the Food and Drug Administration that an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval.
External links
* [http://www.delcath.com/news/2006/022206.htm Delcath Systems, Inc. receives SPA]
* [http://www.medicalnewstoday.com/articles/76339.php BioCryst Pharmaceuticals, Inc. receives SPA]
References
* [http://216.239.51.104/search?q=cache:at4g40fsiAUJ:www.fda.gov/cber/gdlns/protocol.pdf+special+protocol+assessment&hl=en&ct=clnk&cd=1&gl=us&client=firefox-a FDA definition]
Wikimedia Foundation.
2010.
Look at other dictionaries:
ClinicalTrials.gov — is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and is the largest clinical trials database, currently holding registrations from over 93,000 trials from… … Wikipedia
Oncolytics Biotech — Inc. Type Public Traded as TSX: ONC NASDAQ: ONCY Industry Biopharmaceutical … Wikipedia
Ridaforolimus — Systematic (IUPAC) name (1R,2R,4S) 4 [(2R) 2 [(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28Z,30S,32S,35R) 1,18 dihydroxy 19,30 dimethoxy 15,17,21,23,2 … Wikipedia
TroVax — is a cancer vaccine being developed by Oxford BioMedica. No cancer vaccines have been proven to cure cancer or extend life yet, [ [http://www.cancer.gov/cancertopics/factsheet/cancervaccine National Cancer Institute, Cancer Vaccine Fact Sheet,]… … Wikipedia
Contrast-induced nephropathy — Classification and external resources ICD 10 N99.0 ICD 9 586 Co … Wikipedia
Periodontitis — Infobox Disease Name = Periodontal disease Caption = This radiograph shows significant bone loss between the two roots of a tooth. The spongy bone has receded due to infection under tooth, reducing the bony support for the tooth. DiseasesDB =… … Wikipedia
United States — a republic in the N Western Hemisphere comprising 48 conterminous states, the District of Columbia, and Alaska in North America, and Hawaii in the N Pacific. 267,954,767; conterminous United States, 3,022,387 sq. mi. (7,827,982 sq. km); with… … Universalium
Agriculture and Food Supplies — ▪ 2007 Introduction Bird flu reached Europe and Africa, and concerns over BSE continued to disrupt trade in beef. An international vault for seeds was under construction on an Arctic island. Stocks of important food fish species were reported… … Universalium
china — /chuy neuh/, n. 1. a translucent ceramic material, biscuit fired at a high temperature, its glaze fired at a low temperature. 2. any porcelain ware. 3. plates, cups, saucers, etc., collectively. 4. figurines made of porcelain or ceramic material … Universalium
China — /chuy neuh/, n. 1. People s Republic of, a country in E Asia. 1,221,591,778; 3,691,502 sq. mi. (9,560,990 sq. km). Cap.: Beijing. 2. Republic of. Also called Nationalist China. a republic consisting mainly of the island of Taiwan off the SE coast … Universalium
