Browsing Harvard Law School by Keyword "approval"
Now showing items 1-4 of 4
-
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 ... -
Disclosure of the Dealings Between Drug Developing Companies and the FDA Under the Federal Securities Laws
(2002)The purpose of this article is to highlight the main issues raised by the Food and Drug Administration’s (“FDAâ€) approval process relating to new drugs and the treatment ... -
Harmonizing Pharmaceutical Regulation Among the United States, the European Union, and Japan: The ICH Initiative
(2003)The United States, the European Union and Japan comprise 75% of the world's pharmaceutical market and generate 90% of all pharmaceutical research. Recognizing the need for and benefits of harmonized testing standards the ... -
Protecting the Ignorant, the Unthinking and the Credulous: Are the FDA's Efforts to Accelerate the Drug Approval Process Compromising Public Safety?
(2000)Recently, five approved prescription drugs were recalled in a one-year period after the Food and Drug Administration (FDA or the agency) deemed them to be too unsafe for patient use. Notorious among them was fenfluramine ...