Browsing Harvard Law School by Keyword "drug testing"
Now showing items 1-4 of 4
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Adopting the Therapeutic Orphan: An Examination of FDA and Congress: Efforts to Promote the Inclusion of Children in Clinical Drug Studies
(2001)This paper examines both the Food and Drug Administration’s Final Rule, which mandates drug sponsors to conduct pediatric research on their products prior to FDA approval and Section 111 of the Food and ... -
DRUG THERAPY AND PREGNANCY: UNKNOWN RISKS LEAD TO HARD CHOICES [REDACTED VERSION]
(2001)This paper is a proposal to improve the quality of information available to pregnant patients in selecting treatment options. By providing drug companies with extended grants of exclusivity, the FDA has the ability to ... -
No Humans Have Been Injured in the Testing of this Drug: The New Animal Efficacy Rule
(2004)This paper examines the “Animal Efficacy Rule,†a regulation that provides for the approval of products by the FDA when efficacy testing on humans is ethically impossible. It gives a summary ... -
REFORMING DRUG APPROVAL IN THE UNITED STATES: MEASURES NECESSARY TO ALLEVIATE THE CASH CRUNCH FACED BY SMALL BIOTECHNOLOGY COMPANIES
(1995)Over the past decade, the infant biotechnology industry, led by small biotechnology companies, has produced numerous breakthrough drugs which have saved lives, reduced suffering and cut the cost of health care. Given that ...