 | United States - 1988 - 1290 pages
...amendment, par. (1) read as follows: "Рог purposes of this section, the term 'rare disease or condition' means any disease or condition which occurs so Infrequently...respect to any drug shall be made on the basis of the facts and circumstances as of the date such drug is designated under section 526 of the Federal... | |
 | 2000 - 696 pages
...the cost of developing and making available in the United States (as defined in section 7701(a)(9)) a drug for such disease or condition will be recovered from sales in the United States (as so defined) of such drug. Determinations under paragraph (d)(l)(i)(B) of this section with respect... | |
 | 1998 - 584 pages
...the cost of developing and making available in the United States (as defined in section 7701(a)(9)) a drug for such disease or condition will be recovered from sales in the United States (as so defined) of such drug. Determinations under paragraph (d)(1)(i)(B) of this section with respect... | |
 | United States - 1985 - 516 pages
...200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of...respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under this subsection... | |
 | United States - 1986 - 680 pages
...200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of...respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under this subsection... | |
 | United States. Congress House - 1986 - 942 pages
...years ending after such date. "(B) affects more than 200,000 persons in the United States but for which there is no reasonable expectation that the cost of...respect to any drug shall be made on the basis of the facts and circumstances as of the date such drug is designated under section 526 of the Federal... | |
 | United States, United States. Congress. House. Committee on Energy and Commerce - 1987 - 672 pages
...200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of...respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under this subsection... | |
 | United States - 1989 - 516 pages
...persons in the United States, or (B) 1 affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of...recovered from sales in the United States of such drugs, (2) l in the case of a medical device, any disease or condition that occurs so infrequently... | |
| |
For purposes of paragraph (1), the term "rare disease or condition" means any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which there is no reasonable... 
