355:, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. In cases of topically active drugs, the bioequivalence of a drug can be demonstrated by comparing drugs dissolution or transdermal drug absorption is compared with the innovator drug. In cases of systemically active drugs, active drug blood concentration of that drug is compared with the innovator drug.
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328:, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. Electronic submissions of ANDAs have grown by 70% since November 2008. The Section IV challenge has been credited with suppressing new drug innovation.
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374:. At the same time, the brand-name companies can apply for up to five additional years longer patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process. Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation.
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A generic drug product is one that is comparable to a patented drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. All approved products, both innovator and generic, are listed in FDA's
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343:) they are generally not required to include preclinical (animal and in vitro) and clinical (human) trial data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is
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of 1984, also known as the Hatch-Waxman Act. This Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of
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347:(i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the
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Graham, Stuart J. H.; Higgins, Matthew J. (16 October 2009). "Balancing
Innovation and Access: Patent Challenges Tip the Scales".
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as the basis for approving generic copies of drug products was established by the
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Generic drug applications are termed "abbreviated" because (in comparison with a
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in 24 to 36 healthy volunteers. This gives them the rate of absorption, or
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Approved Drug
Products with Therapeutic Equivalence Evaluations
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United States
Department of Health and Human Services
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Regulation of therapeutic goods in the United States
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370:drugs without conducting costly and duplicative
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16:Application for US generic drug approval
326:Center for Drug Evaluation and Research
105:Department of Health and Human Services
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55:Federal Food, Drug, and Cosmetic Act
233:Single Convention on Narcotic Drugs
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457:from websites or documents of the
313:approval for an existing licensed
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490:Concise Encyclopedia of Economics
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495:Library of Economics and Liberty
453: This article incorporates
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303:Abbreviated New Drug Application
185:Abbreviated New Drug Application
392:"DIA Update: News from the FDA"
324:The ANDA is submitted to FDA's
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70:Prescription Drug Marketing Act
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390:Kathie Clark (June 30, 2009).
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527:Food and Drug Administration
251:National Academy of Medicine
110:Food and Drug Administration
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175:Randomized controlled trial
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207:International coordination
218:Uppsala Monitoring Centre
87:Marihuana Tax Act of 1937
65:Controlled Substances Act
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158:Investigational New Drug
423:10.1126/science.1176116
455:public domain material
41:Over-the-counter drugs
115:Department of Justice
341:New Drug Application
153:New Drug Application
190:Fast track approval
99:Government agencies
485:David R. Henderson
37:Prescription drugs
477:Henninger, Daniel
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481:"Drug Lag"
471:FDA source
368:brand-name
315:medication
80:exemptions
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479:(2002).
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487:(ed.).
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132:Process
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168:phases
60:CDAPCA
483:. In
435:S2CID
378:Notes
261:NORML
256:RADAR
228:CIOMS
500:OCLC
427:PMID
307:ANDA
419:doi
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301:An
223:WHO
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120:DEA
49:Law
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Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.
