Browsing Harvard Law School by Keyword "drug approval"
Now showing items 1-3 of 3
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ACCUTANE: POST-APPROVAL DRUG REGULATION IN A RISK MANAGEMENT FRAMEWORK
(2002)The acne drug Accutane lies at the center of a movement to expand post-approval controls on drug regulation in an effort to effectively manage drug risks. Accutane’s regulatory history tracks a trend ... -
The ANDA Patent Certification Requirement and Thirty-Month Stay Provision: Is it Necessary?
(2001)Patent law and the Federal drug approval laws are both rather arcane and complex. The intersection of these two areas in the Hatch-Waxman Act is particularly complicated, and this perhaps explains the failure of the Act ... -
Expediting Oncology Drug Approvals: The Public Backlash Against the FDA and Opportunities to Reform
(2005)The FDA has made great strides over the past twenty years in loosening drug approval regulations to speed important, life-saving treatments to market. However, recent controversies involving anti-depressants for children ...