- 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 ...
- 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; ...
- NLM Digital Collections - FDA oversightPublication: [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 ...
- ... 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 ...
- ... 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 ...
- ... 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 ...
- NLM Digital Collections - Clarification of orphan designation of drugs and biologics for pediatric subpopulations of ...Publication: Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018... 7 The financial incentives provided by orphan-drug designation include tax credits to defray the cost of conducting clinical trials and eligibility for seven years of market exclusivity. ...
- NLM Digital Collections - FDA oversightPublication: [Toronto, Ontario] : Thomson Reuters, 21-December-2020... predict a clinical benefit to patients. Further clinical trials may be required to verify and describe Tazverik's clinical benefit. Tazverik also received Orphan Drug designation, which provides incentives to assist and encourage the ...
- NLM Digital Collections - Cyclopaedia of the practice of medicine (Volume 13)Publication: New York : Wood, 1874-81... these should, therefore, receive special prominence in the designation. After ... as a provisional clinical designation, and hope that, in spite of its ...
- NLM Digital Collections - Requesting FDA feedback on combination products : guidance for industry and FDA staffPublication: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2020... BLA) 30 Design and size of certain clinical trials, Special Protocol clinical studies, or animal studies Assessment 32 Fast Track Designation, Breakthrough Designation Therapy Designation, or Priority Review Submission ...
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