Drug Regulation Reform Act of 1978: Hearings Before the Subcommittee on Health and Scientific Research of the Committee on Human Resources, United States Senate, Ninety-fifth Congress, Second Session on S. 2755 |
Contents
| 22 | |
| 39 | |
| 47 | |
| 56 | |
| 68 | |
| 75 | |
| 82 | |
| 95 | |
| 106 | |
| 131 | |
| 139 | |
| 150 | |
| 161 | |
| 169 | |
| 171 | |
| 172 | |
| 179 | |
| 182 | |
| 183 | |
| 188 | |
| 196 | |
| 199 | |
| 201 | |
| 202 | |
| 203 | |
| 205 | |
| 207 | |
| 209 | |
| 383 | |
| 385 | |
| 390 | |
| 454 | |
| 474 | |
| 487 | |
| 533 | |
| 567 | |
| 571 | |
| 694 | |
| 923 | |
| 948 | |
| 1014 | |
| 1082 | |
| 1093 | |
| 1132 | |
| 1205 | |
| 1458 | |
Other editions - View all
Common terms and phrases
adverse drug reaction advisory committees agency amended APhA application authority believe bill bioavailability CALIFANO Center for Clinical Chairman Clinical Pharmacology Congress consumer Cosmetic Act decisions disclosure dispensed distribution drug application drug approval drug development drug entity drug lag drug product Drug Regulation Reform entities and drug entity or drug establish evaluation export FDA's Federal Federal Food fetal fetus Food and Drug gestational gestational age hearing important industry information labeling informed consent innovation investigations issue legislation licensure manufacturers monograph National Panel patient information patient package inserts permit person petition pharmaceutical pharmacists pharmacy physicians prescribing prescription drugs present procedures proposed protection provisions public health registration Regulation Reform Act regulatory requirements risk safety and effectiveness safety and efficacy scientific Senator KENNEDY Senator SCHWEIKER specific standards STETLER studies Subcommittee subpart surveillance testing therapeutic tion trade secrets
Popular passages
Page 195 - ... (4) Complaints, orders and other process and papers of the board, its member, agent or agency, may be served either personally or by registered mail or by telegraph or by leaving a copy thereof at the principal office or place of business of the person required to be served.
Page 1177 - 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 the effectiveness of 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 or is represented to have under the conditions of use prescribed, recommended,...
Page 1217 - As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting of adequate and wellcontrolled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved...
Page 646 - ... the Act imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that violations will not occur. The requirements of foresight and vigilance imposed on responsible corporate agents are beyond question demanding, and perhaps onerous, but they are no more stringent than the public has a right to expect of those who voluntarily assume positions of...
Page 503 - I want to thank you and the members of your subcommittee for the opportunity to present our views on housing appropriations legislation.
Page 1270 - Today and tomorrow we expect to hear from witnesses representing the Food and Drug Administration and the Department of Health, Education, and Welfare, and from some industry witnesses who have expressed an interest in testifying briefly on these bills.
Page 179 - ... (b) In any proceeding for criminal contempt for violation of an injunction or restraining order issued under this section, which violation also constitutes a violation of this Act, trial shall be by the court or, upon demand of the accused, by a jury.
Page 937 - Isolated case reports, random experience, and reports lacking the details which permit scientific evaluation will not be considered.
Page 448 - ... means: 1. Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug...
Page 73 - Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28 of the United States Code.