Is Rulemaking Old Medicine at the FDA?

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Title:	Is Rulemaking Old Medicine at the FDA?
Author:	Carey, John C.
Citation:	Is Rulemaking Old Medicine at the FDA? (1997 Third Year Paper)
Full Text & Related Files:	jcarey.pdf (384.4Kb; PDF) jcarey.rtf (151.5Kb; RTF file) jcarey.html (161.0Kb; HTML)
Abstract:	The first three parts of this paper describe the major burdens placed on agency rulemaking by each branch of the government over the past thirty years, with specific focus on the burdens that presently affect FDA rulemaking. Part V then analyzes the effect those burdens have had on FDA rulemaking. The analysis will demonstrate that the additional rulemaking requirements likely act to deter rulemaking at the agency. In conclusion, Part VI briefly discusses the type of policymaking in which FDA currently engages as an alternative to rulemaking and describes further research to be done regarding that method of FDA policymaking.
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