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Public Accountability And Medical Device Regulation, Robert B. Leflar
Public Accountability And Medical Device Regulation, Robert B. Leflar
Robert B Leflar
In enacting the Medical Device Amendments of 1976, Congress instituted a flexible system of regulatory controls over a vast array of health care products. Analyzing the complex statute and its legislative history, Professor Leflar finds at the law's core a structure designed to ensure the Food and Drug Administration's accountability to the public for its regulatory actions. Reviewing the history of FDA's implementation of the medical device law, however, the author demonstrates that FDA has strayed widely and, he contends, illegally from the congressionally mandated structure of public accountability. In particular, in its review of new-model medical devices in the …
Letting Statutory Tails Wag Constitutional Dogs - Have The Bivens Dissenters Prevailed?, George D. Brown
Letting Statutory Tails Wag Constitutional Dogs - Have The Bivens Dissenters Prevailed?, George D. Brown
George D. Brown
No abstract provided.