Should the Food and Drug Administration (FDA)'s determination that a product is safe negate a private litigant's cause of action under state law in all circumstances, unless the FDA determines that the manufacturer withheld relevant information regarding the safety of the product? This Note concludes that such federal preemption is proper because the FDA is fully capable of making a determinati...

FDA starts light-touch inspections for some imports.

(a) Because extralabel use of animal and human drugs in nonfood-producing animals does not ordinarily pose a threat to the public health, extralabel use of animal and human drugs is permitted in nonfood-producing animal practice except when the public health is threatened. In addition, the provisions of § 530.20(a)(1) will apply to the use of an approved animal drug. (b) If FDA determines that ...

U.S. Food and Drug Administration (FDA) policy prohibits blood donation from men who have had sex with men (MSM) even one time since 1977. Growing moral criticism claims that this policy is discriminatory, a claim rejected by the FDA. An overview of U.S. blood donation, recent donor deferral policy, and the conventional ethical debate introduce the need for a different approach to analyzing dis...

Conference on Clinical Cancer Research November 2012 Re-evaluating Criteria for Accelerated Approval Richard L. Schilsky, Chief, Section of Hematology-Oncology, University of Chicago Medical Center David P. Schenkein, CEO, Agios Pharmaceuticals Wyndham H. Wilson, Senior Investigator, Chief, Lymphoma Therapeutics Section, NCI Cheryl L. Jernigan, Research/Patient Advocate, Susan G. Komen fo...

In a widely cited article, DiMasi, Hansen, and Grabowski (2003) estimate the average pre-tax cost of bringing a new molecular entity to market. Their base case estimate, excluding post-marketing studies, was $802 million (in $US 2000). Strikingly, almost half of this cost (or $399 million) is the cost of capital (COC) used to fund clinical development expenses to the point of FDA marketing appr...