38:
295:, required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval. The majority of the tragic birth defects that occurred were in other countries because Thalidomide had not been approved for use in the United States. However, samples were distributed to physicians in the US and 17 birth defects were attributed to its use.
302:
It introduced a "proof-of-efficacy" requirement for the first time. In addition, the
Amendment required drug advertising to disclose accurate information about side effects and efficacy of treatments. Finally, cheap generic drugs could no longer be marketed as expensive drugs under new trade names as
260:
It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as expensive drugs under new trade names as
48:
An act to protect the public health by amending the
Federal Food, Drug, and Cosmetic Act to assure the safety, effectiveness, and reliability of drugs, authorize standardization of drug names, and clarify and strengthen existing inspection authority; and for other
380:" (a 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938) certain animal drugs and animal feed additives shown to induce cancer, but which left no detectable levels of residue in the human food supply.
330:
are approved and regulated. Before the
Thalidomide scandal in Europe, and Canada, U.S. drug companies only had to show their new products were safe. After the passage of the Amendment, an FDA
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tragedy, in which thousands of children were born with birth defects as a result of their mothers taking thalidomide for morning sickness during pregnancy. The bill by
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was begun to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.
373:, advised Congress about the proper conduct of clinical research during the 1962 hearings leading up to passage of the Amendment.
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180:
602:
421:
113:
105:
612:
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75:
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Abood, R.R., & Brushwood, D.B. (1994). Pharmacy practice and the law. Gaithersburg, MD: Aspen
Publishers, Inc.
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Krantz JC Jr., New Drugs and the
Kefauver–Harris Amendment, J New Drugs, 1966, Mar-Apr;6(22):77-9
566:
Krantz JC Jr., The
Kefauver-Harris amendment after sixteen years, Mil Med. 1978 Dec;143(12):883.
538:
477:
Jurisdiction to Decide an Agency's Own
Jurisdiction: The Forgotten Tale of the Hynson Quartet
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334:(NDA) would have to show that a new drug was both safe and effective. Previously the 1938
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448:. The Journal of Political Economy, Vol. 81, No. 5. (Sep. - Oct., 1973), pp. 1051.
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An
Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments
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was the FDA reviewer who refused to approve
Thalidomide for use.
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was required of patients participating in clinical trials, and
494:"Kefauver-Harris Amendments Revolutionized Drug Development"
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or "Drug
Efficacy Amendment" is a 1962 amendment to the
483:, Vol. 58, No. 4 (Fall 2006), pp. 829-843 (15 pages).
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considered the Amendment his "finest achievement" in
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586:, Enrolled Acts and Resolutions of Congress at the
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459:"Promoting Safe and Effective Drugs for 100 Years"
369:, then a prominent clinical pharmacologist at the
588:U.S. National Archives and Records Administration
318:The Kefauver–Harris Amendment strengthened the
338:was the main law that regulated drug safety.
27:1962 United States federal health legislation
8:
30:
580:from the U.S. Food and Drug Administration
216:Reported by the joint conference committee
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346:were required to be reported to the FDA.
608:United States federal health legislation
578:50 Years: The Kefauver-Harris Amendments
434:
29:
7:
465:. U.S. Food and Drug Administration.
412:Federal Food, Drug, and Cosmetic Act
269:The amendment was a response to the
255:Federal Food, Drug, and Cosmetic Act
133:Federal Food, Drug, and Cosmetic Act
463:The Kefauver-Harris Drug Amendments
402:Drug Efficacy Study Implementation
351:Drug Efficacy Study Implementation
25:
517:"Canadian Thalidomide Experience"
320:U.S. Food and Drug Administration
175:in the Senate as S. 1552 by
376:The law also exempted from the "
371:Johns Hopkins School of Medicine
306:The law was signed by President
303:new "breakthrough" medications.
261:new "breakthrough" medications.
230:on October 4, 1962 (passed)
212:on August 23, 1962 (passed)
36:
422:Regulation of therapeutic goods
1:
584:Drug Amendments Act of 1962
336:Food, Drug and Cosmetic Act
76:87th United States Congress
629:
195:Senate Judiciary Committee
515:Webb JF (November 1963).
481:Administrative Law Review
407:Durham-Humphrey Amendment
324:experimentation on humans
251:Kefauver–Harris Amendment
222:on October 4, 1962 (
202:on August 23, 1962 (
168:
143:21 U.S.C.: Food and Drugs
63:Kefauver–Harris Amendment
35:
326:and changed the way new
191:Committee consideration
149:U.S.C. sections amended
60:Drug Efficacy Amendment
31:Drug Amendments of 1962
18:Drug Efficacy Amendment
603:Pharmaceuticals policy
344:adverse drug reactions
220:agreed to by the House
417:Frances Oldham Kelsey
310:on October 10, 1962.
297:Frances Oldham Kelsey
613:1962 in American law
396:Directive 65/65/EEC1
391:Criticism of the FDA
332:New Drug Application
218:on October 4, 1962;
361:consumer protection
286:U.S. Representative
240:on October 10, 1962
164:Legislative history
32:
187:) on July 19, 1962
475:O'Reilly, James,
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200:Passed the Senate
107:Statutes at Large
16:(Redirected from
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500:. Archived from
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340:Informed consent
210:Passed the House
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85:October 10, 1962
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308:John F. Kennedy
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238:John F. Kennedy
234:Signed into law
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71:Enacted by
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129:Acts amended
124:Codification
498:www.fda.gov
289:Oren Harris
271:thalidomide
597:Categories
429:References
265:Background
173:Introduced
95:Public law
45:Long title
282:Tennessee
249:The U.S.
153:21 U.S.C.
90:Citations
82:Effective
54:Nicknames
49:purposes.
543:14076167
398:(Europe)
384:See also
293:Arkansas
112:76
554:Sources
534:1921912
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314:Effect
284:, and
228:Senate
224:347–88
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99:87-781
328:drugs
291:, of
280:, of
204:78–22
157:ch. 9
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114:Stat.
539:PMID
349:The
74:the
529:PMC
193:by
118:780
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437:^
363:.
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185:TN
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183:–
181:D
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