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ANDA suitability petitions: The proc...

Cottrell, Sandra C.

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ANDA suitability petitions: The process of extending generic eligibility as part of the Drug Price Competition-Patent Term Restoration Act of 1984. An analysis of data from enactment through December, 1989.

Record Type:	Electronic resources : Monograph/item
Title/Author:	ANDA suitability petitions: The process of extending generic eligibility as part of the Drug Price Competition-Patent Term Restoration Act of 1984. An analysis of data from enactment through December, 1989./
Author:	Cottrell, Sandra C.
Description:	423 p.
Notes:	Source: Dissertation Abstracts International, Volume: 57-01, Section: B, page: 0263.
Contained By:	Dissertation Abstracts International57-01B.
Subject:	Health Sciences, Pharmacy. -
Online resource:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=9227447

ANDA suitability petitions: The process of extending generic eligibility as part of the Drug Price Competition-Patent Term Restoration Act of 1984. An analysis of data from enactment through December, 1989.
Cottrell, Sandra C.

ANDA suitability petitions: The process of extending generic eligibility as part of the Drug Price Competition-Patent Term Restoration Act of 1984. An analysis of data from enactment through December, 1989. - 423 p.

Source: Dissertation Abstracts International, Volume: 57-01, Section: B, page: 0263.

Thesis (Ph.D.)--Temple University, 1992.

On September 24, 1984, the Drug Price Competition--Patent Term Restoration (DPC-PTR) Act (Pub. L 98-417) was signed into law, amending section 505 of the Food, Drug, and Cosmetic Act (21 U.S.C. 355). The amendment represented the culmination of Congressional efforts to achieve two distinct and, in principle, opposing objectives: to provide a mechanism to assure the timely marketing of generic versions of brand name drugs, and to provide increased incentives for pioneer drug research and development, which would help to offset the increased expenditure of time and resources necessary to bring a new drug to market. Within the complexity of this legislation, there is a specific mechanism for a potential generic manufacturer to make modifications of a generic drug product qualify for an abbreviated regulatory process which would not otherwise be eligible for such a process. This mechanism utilizes a suitability (deviation) petition to which, by regulation, the Food and Drug Administration is to respond within 90 days of application.Subjects--Topical Terms:

1017737
Health Sciences, Pharmacy.

ANDA suitability petitions: The process of extending generic eligibility as part of the Drug Price Competition-Patent Term Restoration Act of 1984. An analysis of data from enactment through December, 1989.
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245 1 0 $a ANDA suitability petitions: The process of extending generic eligibility as part of the Drug Price Competition-Patent Term Restoration Act of 1984. An analysis of data from enactment through December, 1989.
300 $a 423 p.
500 $a Source: Dissertation Abstracts International, Volume: 57-01, Section: B, page: 0263.
500 $a Major Adviser: Murray Tuckerman.
502 $a Thesis (Ph.D.)--Temple University, 1992.
520 $a On September 24, 1984, the Drug Price Competition--Patent Term Restoration (DPC-PTR) Act (Pub. L 98-417) was signed into law, amending section 505 of the Food, Drug, and Cosmetic Act (21 U.S.C. 355). The amendment represented the culmination of Congressional efforts to achieve two distinct and, in principle, opposing objectives: to provide a mechanism to assure the timely marketing of generic versions of brand name drugs, and to provide increased incentives for pioneer drug research and development, which would help to offset the increased expenditure of time and resources necessary to bring a new drug to market. Within the complexity of this legislation, there is a specific mechanism for a potential generic manufacturer to make modifications of a generic drug product qualify for an abbreviated regulatory process which would not otherwise be eligible for such a process. This mechanism utilizes a suitability (deviation) petition to which, by regulation, the Food and Drug Administration is to respond within 90 days of application.
520 $a After a relevant review of the history of the Act and the details of the DPC-PTR Act of 1984, this dissertation examines how industry, collectively, is using this petitioning process and how the FDA is responding. To achieve this objective, all suitability petitions which have been submitted since enactment, through December, 1989, were entered into a computer data base. The petitions were analyzed in order to examine FDA's and industry's responses to this feature of the legislation. $\ sp* $ ftn $\ sp*
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