Results 91 to 100 of about 5,545,002 (288)
FDA Drug Approval: A Black and White Issue? [PDF]
, 2012 The FDA should judiciously limit the FDA approval of race-specific drugs to situations in which the utilization of racial categories is based on statistically significant scientific data and necessity and, in such cases, the meaning of race utilized ...
Yonker, Stephanie A.
core
The experience of accommodating privacy restrictions during implementation of a large-scale surveillance study of an osteoporosis medication. [PDF]
, 2016 PurposeTo explore whether privacy restrictions developed to protect patients have complicated research within a 15-year surveillance study conducted with US cancer registries.MethodsData from enrolling 27 cancer registries over a 10-year period were ...
Andrews, Elizabeth B +6 more
core +1 more source
Frontiers in PharmacologyObjective:Since 2016, China has successively implemented Accelerated Drug Marketing Registration Procedures (ADMRPs) for drugs, including Breakthrough Therapy Drug (BTD), Conditional Approval (CA), and Priority Review and Approval (PRA), which have ...
Yipeng Lan +7 more
doaj +1 more source
Archives of Pathology & Laboratory Medicine, 2018 April 12, 2017 marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology.
A. Evans +14 more
semanticscholar +1 more source
An Analysis of New Drug Examination and Approval System of PRC [PDF]
, 2012 This paper analyzes the new drug examination and approval systems before and after the Measures was amended in 2007 and evaluates the effectiveness of the 2007 Amendment.
Sun, Xiaopu
core
Clinical Trial 2.0: Can Health 2.0 Transform the FDA Drug Approval Process? [PDF]
, 2012 Historically, patient activism has played a great part in shaping the drug approval process. Today, aided by developing web technologies, patients are once again seeking increased involvement in their medical care.
Atanassova, Mira
core
Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]
, 2014 A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core +3 more sources
Regulating Access to Developmental Drugs for Terminally Ill Patients: Abigail Alliance v FDA [PDF]
This amicus brief was filed in support of the Abigail Alliance for Better Access to Developmental Drugs in their lawsuit to force the Food and Drug Administration to provide patient access to drugs for cancer and other life-threatening illnesses after ...
Calfee, John E. +4 more
core +1 more source
Adaptive Minimax-Regret Treatment Choice, With Application To Drug Approval [PDF]
Suppose that there are two treatments for a condition. One is the status quo, whose properties are known from experience and the other is an innovation, whose properties are not known initially.
Charles F. Manski
core +3 more sources
Cancer MedicineBackground Hundreds of cancer drugs are approved globally based on surrogate endpoint response rate (RR). However, the characteristics of RR‐based approvals remain unknown.
Ting Zhu, Jinjia Zhong, Yafang Huang
doaj +1 more source