FDA reform and the European Medicines Evaluation Agency
Article Abstract:
The US Food and Drug Administration's (FDA) pharmaceuticals approval system should benefit from both cooperation and competition with the newly established European Medicines Evaluation Agency (EMEA). The FDA has ben criticized for the length of time that drug approvals take, and some critics have suggested that pre-marketing approval be used. Accelerated approvals from the European Community's EMEA may accelerate FDA processes. Working with the EMEA to establish joint approval procedures may improve FDA performance as well.
Publication Name: Harvard Law Review
Subject: Law
ISSN: 0017-811X
Year: 1995
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Reform of the new drug approval process
Article Abstract:
Legislative reforms of the Food and Drug Administration's (FDA) pharmaceutical testing procedures must link policies aiming for market efficiency and agency accountability to an independent oversight body. The FDA's traditional cautionary approach tended to delay the marketing of safe pharmaceutical products. An independent oversight body would encourage the FDA to consider the need for efficiency in the marketplace in its testing policies and procedures so new, safe products can meet consumer demands.
Publication Name: Administrative Law Review
Subject: Law
ISSN: 0001-8368
Year: 1997
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Some FDA applications can escape full testing; draft guidance suggests that in many cases, studies conducted by others will be acceptable
Article Abstract:
A draft guidance by the FDA regarding agency approval of applications for new drugs submitted under Section 505(b)(2) of the Food, Drug, and Cosmetic Act. This statutory section may now be used to secure the approval of a variety of products without submission of complete safety and effectiveness data.
Publication Name: The National Law Journal
Subject: Law
ISSN: 0162-7325
Year: 2000
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