When the Alpha is the Omega: P-Values, "Substantial Evidence," and the 0.05 Standard at FDA [0.03%]
当Alpha亦是Omega时：P值，“显著证据”以及FDA的0.05标准
Lee Kennedy-Shaffer
Lee Kennedy-Shaffer
A prominent feature of statistical reasoning for nearly a century, the p-value plays an especially vital role in the clinical testing of new drugs. Over the last fifty years, the U.S. Food and Drug Administration (FDA) has relied on p-value...
FDA's Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence [0.03%]
美国食品和药物管理局在H部分灵活审批中的功效性证据评估标准：程度问题？
Frank J Sasinowski,Alexander J Varond
Frank J Sasinowski
This article examines the strength of scientific and clinical evidence for FDA's nineteen non-AIDS, non-cancer Subpart H approval determinations over the Accelerated Approval program's twenty-four year existence. The authors researched the ...
FDA's Troubling Failures to Use its Authority to Regulate Genetically Modified Foods [0.03%]
美国食品药物管理局在监管转基因食品方面令人忧心的失职行为
Leslie Francis,Robin Kundis Craig,Erika George
Leslie Francis
Steven Raper
Steven Raper
Xiao Zhu,Michael T Roberts,Kaijie Wu
Xiao Zhu
Facing a tension between the increasing use of genetically engineered or modified food and consumer concerns over the risks associated with GMOs, China has established a GM food labeling regime through regulations-known as Agro-GMO regulati...
THE CHICKEN AND THE EGG - ANIMAL WELFARE, FOOD SAFETY AND FEDERALISM [0.03%]
鸡生蛋还是蛋生鸡——动物福利、食品安全和联邦主义
Rita-Marie Cain Reid
Rita-Marie Cain Reid
Micah L Berman,M Justin Byron,Natalie Hemmerich et al.
Micah L Berman et al.
The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) requires tobacco companies to disclose information about the harmful chemicals in their products to the U.S. Food and Drug Administration (FDA). The law requires the FDA, in t...
A Recipe for Justice: Support for a Federal Food Justice Interagency Working Group [0.03%]
正义的配方：支持设立联邦食品正义部门间工作组
Melanie Pugh
Melanie Pugh
Systemic social justice issues are characterized as having complex and far-reaching causes. Food justice is one such an issue. Food justice is defined as “justice for all [people] in the food system,” from agricultural production to consu...
Alison Peck
Alison Peck
Biotechnology is about to spill the banks of federal regulation. New genetic engineering techniques like CRISPR-Cas9 promise revolutionary breakthroughs in medicine, agriculture, and public health—but those techniques would not be regulate...
Emilie Aguirre
Emilie Aguirre
We face a global antibiotics resistance crisis. Antibiotic drugs are rapidly losing their effectiveness, potentially propelling us toward a post-antibiotic world. The largest use of antibiotics in the world is in food-producing animals. Foo...