 | United States - 1977 - 1276 pagini
...As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting of adequate and well-controlled...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e) Withdrawal of approval; grounds; immediate... | |
 | United States - 1964 - 1098 pagini
...effectiveness of the drug involved, on the basis of which it could fairly TITLE 21.— POOD AND DRUGS Page 1142 and responsibly be concluded by such experts that...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e) Withdrawal of approval; grounds; immediate... | |
 | 1971 - 676 pagini
...applicable to show whether or not the drug Is safe and effective for use as suggested In the labeling. b. An application may be refused unless It Includes...recommended, or suggested in the proposed labeling. Chapter I — Food and Drug Administration c. Reports oí all clinical tests sponsored by •the applicant... | |
 | 1979 - 1056 pagini
...other information before the Food and Drug Administration with respect to such drug, there is lack of substantial evidence consisting of adequate and well-controlled...recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period of years and are recognized by the... | |
 | 1977 - 1080 pagini
...may be refused unless It Includes substantial evidence consisting of adequate and well -con trolled Investigations, Including clinical Investigations,...recommended, or suggested In the proposed labeling. c. Reports of all clinical tests sponsored by the applicant or received or otherwise obtained by the applicant... | |
 | 1986 - 1610 pagini
...adequately ensure safety and efficacy of use. "Substantial evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...purports or is represented to have under the conditions prescribed, recommended, or suggested in the labeling or proposed labeling thereof." This definition... | |
 | 1990 - 1086 pagini
...adequately ensure safety and efficacy of use. "Substantial evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...purports or is represented to have under the conditions prescribed, recommended, or suggested in the labeling or proposed labeling thereof." This definition... | |
 | 1998 - 1120 pagini
...adequately ensure safety and efficacy of use. "Substantial evi-dence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...purports or is represented to have under the conditions prescribed, rec-ommended, or suggested in the labeling or proposed labeling thereof." This def-inition... | |
 | 1996 - 618 pagini
...evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have...recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period of years and are recognized by the... | |
 | 1989 - 760 pagini
...evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have...recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period of years and are recognized by the... | |
| |
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... 
