 As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate...  Competitive problems in the drug industry: hearings before Subcommittee on ... - Page 10805by United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly and Anticompetitive Activities, United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - 1967 - 15579 pagesFull view - About this book
 | David A. Gettman, Dean Arneson - Medical - 2003 - 452 pages
...Substantial evidence is defined in the act as follows: evidence consisting of adequate and well-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports... | |
 | Tatiana Shohov - Constitutional law - 2003 - 154 pages
..."substantial evidence" which is defined as evidence: . . . consisting of adequate and well-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or... | |
 | Shein-Chung Chow, Hansheng Wang, Jun Shao - Mathematics - 2003 - 376 pages
...Drug and Cosmetics Act in 1962 is defined as the evidence consisting of adequate and well-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports... | |
 | Douglas Holtz-Eakin, Harvey S. Rosen - Business & Economics - 2003 - 244 pages
...is defined by section 505(d) of the FD&C Act as "evidence consisting of adequate and well-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could be fairly and responsibly concluded by such experts that the drug will have the effect it purports or... | |
 | Robert M. Winslow - Science - 2005 - 576 pages
...Winslow. ISBN- 13: 978-0- 12-759760-7 ISBN- 10: 0- 12-759760-3 consisting of adequate and well-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports... | |
 | Ronald C. Kessler, Paul E. Stang - Business & Economics - 2006 - 317 pages
...means evidence consisting of adequate and well-controlled investigations [defined in 21 CFR 314.126], including clinical investigations, by experts qualified...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports... | |
 | Stephen Skowronek, Matthew Glassman - United States - 2007 - 464 pages
...or may be refused unless it includes substantial evidence consisting of adequate and well-controlled investigations, by experts qualified by scientific...the drug involved, on the basis of which it could fairly and responsibly be concluded that the drug will have the effect it purports or is represented... | |
 | Administrative law - 1964 - 1248 pages
...respect to such drug, there is lack of substantial evidence consisting of adequate and well-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports... | |
 | Administrative law - 1971 - 704 pages
...respect to such drug, there is lack of substantial evidence consisting of adequate and well-controlled investigations, including clinical investigations,...the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports... | |
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