Browsing Harvard Law School by Keyword "FDA regulation"
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Ain't Misbehavin'? An Analysis of Prescription Drug Promotions by Pharmaceutical Manufacturers and the Regulatory Response of the Food and Drug Administration
(2003)In evaluating the United States drug regulatory system in 1978, Richard J. Crout posed a choice between competing good values: "Do we want scientific rationality or personal freedom? And if we want the latter, are we willing ... -
THE CAPITAL CRISIS IN BIOTECH AND THE INVISIBLE COSTS OF REGULATION
(1995)This paper argues that while the FDA approval process may be trivial in terms of geologic time, it is an eternity when viewed from the perspective of the biotech industry. A delay of even a few months can mean life or death ... -
HUMAN CLONING AND FDA REGULATION
(1998)In the February 27, 1997 issue of the journal Nature scientists from Scotland's Roslin Institute reported their successful efforts to clone an adult sheep using differentiated somatic cells from the animal. The clone, named ...