Designer Drugs: Hearing Before the Subcommittee on Crime of the Committee on the Judiciary, House of Representatives, Ninety-ninth Congress, First Session, on H.R. 2014, H.R. 2977, H.R. 3936, and S. 1437, May 1, 1986 |
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Page 4
... reference to the exemption from the new drug approval require- ment for investigational use . Also , nonclinical research and indus- trial applications would not be affected since they are not intended for human consumption . In short ...
... reference to the exemption from the new drug approval require- ment for investigational use . Also , nonclinical research and indus- trial applications would not be affected since they are not intended for human consumption . In short ...
Page 35
... reference to the exemption from the new - drug approval requirement for investi- gational use , 21 U.S.C. $ 355 . Thus , the bill does not prohibit scientists from developing new drugs that are similar to con- trolled substances . It ...
... reference to the exemption from the new - drug approval requirement for investi- gational use , 21 U.S.C. $ 355 . Thus , the bill does not prohibit scientists from developing new drugs that are similar to con- trolled substances . It ...
Page 60
... reference to the already existing protocol , the already existing authority which is the FDA , and we don't try and change that in any way , such that as long as they are following approved procedures that are currently in the law they ...
... reference to the already existing protocol , the already existing authority which is the FDA , and we don't try and change that in any way , such that as long as they are following approved procedures that are currently in the law they ...
Page 67
... reference spectra and analytical methodolo- gies . The substances may be hundreds of times more potent than known drugs and thus may appear in minute quantities or mixed with other drugs . Medical examiner's offices and hospital ...
... reference spectra and analytical methodolo- gies . The substances may be hundreds of times more potent than known drugs and thus may appear in minute quantities or mixed with other drugs . Medical examiner's offices and hospital ...
Page 73
... reference spectra and analytical methodologies . The substance may be hundreds of time more potent than known drugs and thus may appear in minute quantities or mixed with other drugs . Medical examiner's offices and hospital ...
... reference spectra and analytical methodologies . The substance may be hundreds of time more potent than known drugs and thus may appear in minute quantities or mixed with other drugs . Medical examiner's offices and hospital ...
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Common terms and phrases
amended amphetamine appropriate approval Attorney bill California Chairman chemical structure chemists clandestine laboratories Committee compounds conducted CONGRESS THE LIBRARY controlled substance analogs Controlled Substances Act Cosmetic Act criminal Department of Health designer drug manufacture designer drug problem drug abuse Drug Enforcement Drug Enforcement Administration drug or substance effect emergency scheduling exemption Federal Food fentanyl analogs fetus Florida Food and Drug GRINSPOON HAWKS Health and Human heroin HUGHES human consumption Human Services human subjects illegal illicit drug individuals informed consent Institutional Review Board intended for human intent to distribute investigational law enforcement legislation legitimate research LIBRARY OF CONGRESS LUNGREN MCCOLLUM MDMA meperidine MPPP MPTP NIDA paragraph Parkinson's disease potential procedures produce programs public health regulations research involving Secretary of Health Senator CHILES specific statement studies subpart substance in Schedules substantially similar synthetic Thank therapeutic tion Tocus toxicity trolled substance
Popular passages
Page 39 - I would be pleased to respond to any questions you or members of the committee may have.
Page 178 - Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Page 178 - Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (ie, the identity of the subject is or may readily be ascertained by the investigator or...
Page 33 - No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) is effective with respect to such drug.
Page 178 - ... for determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review...
Page 177 - Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available, or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Page 179 - Except when an expedited review procedure is used (see § 46. 1 10), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
Page 185 - The purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or (2) the risk to the fetus is minimal.
Page 178 - A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to federal regulation.
Page 188 - The risk represents a minor increase over minimal risk; (b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; 45 CFR Subtitle A (10-1-93 Edition) (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects...