Rendre évident : une approche symétrique de la réglementation des produits thérapeutiques

Abstract

Quand le vivant devient politique : les avatars de la démocratie technique Volume 42, numéro 2, automne 2010 URI : id.erudit.org/iderudit/045360ar

Regulators, Pivotal Clinical Trials, and Drug Regulation in the Age of COVID-19

“…Flexibility is desirable and necessary because the data require interpretation and the balance between benefit and harm can be hard to determine. 23 However, how this flexibility is expressed should be transparent and justified so that both health care providers and the public understand the rationale for the decisions regulators make. Yet, recent changes to the FDA's review process-replacing individual scientific reviews that often contain a wealth of information that is not available elsewhere, as well as conflicting interpretations of the evidence, 24 with one "integrated review"-stand to further obscure regulatory decision-making.…”

Unlocking Health Canada’s cache of trade secrets: mandatory disclosure of clinical trial results

“…The saga surrounding Merck's pained withdrawal of Vioxx from the market as well as ethnographic studies of Health Canada suggest that regulators can lose touch with that distinction. 39,40 Keeping clinical trial data confidential indicates sympathy for industry's (unproven) claim that clinical trials secrecy is integral to the development of therapeutic products and devices.…”