Results 131 to 140 of about 25,471 (263)

The FDA, Preemption, and Public Safety: Antiregulatory Effects and Maddening Inconsistency [PDF]

, 2011
Most people think of preemption as a technical constitutional doctrine, but it is pivotally important to health and safety, while also opening the door to broad judicial discretion.
Gostin, Lawrence O.
core   +1 more source

Informed consent to postmarketing research [PDF]

, 1995
Nicholas Cox
openalex   +1 more source

Impact of body mass index on the efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes mellitus: A subgroup analysis of 3‐month interim results from the Specified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use study

Journal of Diabetes Investigation, 2019
Aims/Introduction Specified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use is an ongoing postmarketing study of ipragliflozin for long‐term use in Japanese patients with type 2 diabetes mellitus.
Kazuyuki Tobe, Hiroshi Maegawa, Hiromi Tabuchi, Ichiro Nakamura, Satoshi Uno   +4 more
doaj   +1 more source

Characteristics of “Hard-to-Use” Press-Through-Package Sheets: An Analysis of Information Collected by Marketing Specialists of a Japanese Medical Wholesaler

Patient Preference and Adherence, 2020
Kenji Kabeya,1 Hiroki Satoh,2,3 Satoko Hori,4 Yasumasa Miura,5 Yasufumi Sawada2 1Faculty of Pharmaceutical Sciences, The University of Tokyo, Tokyo 113-0033, Japan; 2Laboratory of Drug Lifetime Management, Graduate School of Pharmaceutical Sciences, The ...
Kabeya K, Satoh H, Hori S, Miura Y, Sawada Y   +4 more
doaj  

Tolerability of sumatriptan: clinical trials and postmarketing experience [PDF]

, 2001
Christopher Allen, Jeffrey Dayno
openalex   +1 more source

Occurrence of Pulmonary Oil Microembolism After Testosterone Undecanoate Injection: A Postmarketing Safety Analysis

Sexual Medicine, 2020
Background: The Aveed Risk Evaluation and Mitigation Strategy program was instituted because of potential risk of pulmonary oil microembolism (POME) and/or anaphylaxis after intramuscular injection of Aveed (testosterone undecanoate), indicated for ...
Alexander W. Pastuszak, MD, PhD, Yiqun Hu, MD, PhD, Jeffrey D. Freid, MD   +2 more
doaj  

A Postmarketing Surveillance Study of Gabapentin as Add‐on Therapy for 3,100 Patients in England [PDF]

, 2002
Lynda V. Wilton, Saad Shakir
openalex   +1 more source

Fat Redistribution in Indinavir-Treated Patients With HIV Infection: A Review of Postmarketing Cases

, 2000
Joan O. Benson, Kay McGhee, Paul Coplan, Carl Grünfeld, Michael Robertson, Kimberly G. Brodovicz, Eve E. Slater   +6 more
openalex   +2 more sources

No Humans Have Been Injured in the Testing of this Drug: The New Animal Efficacy Rule [PDF]

, 2012
This paper examines the “Animal Efficacy Rule,†a regulation that provides for the approval of products by the FDA when efficacy testing on humans is ethically impossible.
Campbell, Carrie
core  

Postmarketing Surveillance of New Antiepileptic Drugs: The Tribulations of Trials [PDF]

, 2002
Jacqueline A. French
openalex   +1 more source