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2,109 results
  1. ... heading equivalents or near-equivalents - these include such designations as CLINICAL TRIAL, RETRACTION OF PUBLICATION, DUPLICATE PUBLICATION, and CONSENSUS DEVELOPMENT ...
  2. ... States.[ 1 - 3 ] Neoadjuvant chemotherapy as given in ... the designation, neoadjuvant, to distinguish it from standard adjuvant therapy, ...
  3. NLM Digital Collections - Orphan drugs : FDA could improve designation review consistency; rare disease drug ... 
    Publication: Washington, DC : United States Government Accountability Office, November 2018
    ... indications. The approved indication is based on the clinical trial data provided in the manufacturer’s marketing application and is typically narrower than the orphan designation, which is based on early drug development data ...
  4. ... devices being evaluated under investigational device exemptions (IDE) designations by the FDA, certain medical and surgical procedures being provided in qualifying clinical trials, and certain technologies whose coverage has been legislatively ...
  5. NLM Digital Collections - High-expenditure Medicare drugs often qualified for Orphan Drug Act incentives designed to ... 
    Publication: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2021
    ... the development of qualified orphan drugs Orphan Drug Designation a tax credit equaling 25 percent of the qualifying clinical trial costs for the orphan-designated disease or condition; ...
  6. ... describe recommended basic standards for the collection of clinical trial data. ... (highly recommended, recommended/conditional, or optional). Version 1. ...
  7. NLM Digital Collections - FDA oversight 
    Publication: [Toronto, Ontario] : Thomson Reuters, 23-December-2019
    ... predict a clinical benefit to patients. Further clinical trials are required to verify and describe Xpovio's clinical benefit. The FDA granted this application Fast Track designation. Xpovio also received Orphan Drug designation, which provides ...
  8. ... but 11 of them were still not in clinical trials. Six had received high priority designation from six months to a year, earlier.2* Sixteen drugs were actually being tested, but only 3,431 persons were involved ... clinical trials is aerosolized pentamidine. Thirteen months before the ...
  9. ... but 11 of them were still not in clinical trials. Six had received high priority designation from six months to a year earlier.2* Sixteen drugs were actually being tested, but only 3,431 persons were involved ... clinical trials is aerosolized pentamidine. Thirteen months before the ...
  10. ... but 11 of them were still not in clinical trials. Six had received high priority designation from six months to a year earlier.2* Sixteen drugs were actually being tested, but only 3,431 persons were involved ... clinical trials is aerosolized pentamidine. Thirteen months before the ...
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