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Full-Text Articles in Law
Regulating Compounding Pharmacies After Necc, Kevin Outterson
Regulating Compounding Pharmacies After Necc, Kevin Outterson
Faculty Scholarship
Food and Drug Administration (FDA) rules are often forged in crisis. After the 1937 sulfanilamide disaster that killed more than 100 people, Congress passed the Food, Drug, and Cosmetic Act (FDCA),requiring drugs to be safe and properly labeled. In 1962, a requirement was introduced for proof of drug efficacy through “adequate and well-controlled investigations,” partly in response to the thalidomide tragedy. Rules protecting human-research subjects owe a debt to Tuskegee and Nuremberg.
A Randomized Study Of How Physicians Interpret Research Funding Disclosures, Christopher Robertson
A Randomized Study Of How Physicians Interpret Research Funding Disclosures, Christopher Robertson
Faculty Scholarship
The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians’ reactions to trials with a high, medium, or low level of methodologic rigor.