Results 71 to 80 of about 13,126 (223)

Additional file 1: of Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

, 2019
Box S1. (The history of US Food and Drug Administration’s postmarketing commitments and requirements). Box S2. (Postmarketing commitment reporting requirements). Box S3. (Postmarking commitment categorization). Box S4.
Sanket Dhruva (6846314), Anita Luxkaranayagam (6846311), Jennifer Miller (810455), Joshua Wallach (4741575), Joseph Ross (3435704)   +4 more
core   +1 more source

Postmarketing Trials and Pediatric Device Approvals

, 2017
BACKGROUND: Medical devices can be useful in a variety of diseases, but few devices have been specifically approved for use in children. The 2007 Pediatric Medical Device Safety and Improvement Act was passed to stimulate pediatric device development ...
Kesselheim, Aaron, Bourgeois, Florence, Hwang, Thomas   +2 more
core   +1 more source

Regulatory pathways, study characteristics of pivotal clinical trials, and postmarketing expectations for selected TB, HIV, and HCV NCEs.

, 2022
Regulatory pathways, study characteristics of pivotal clinical trials, and postmarketing expectations for selected TB, HIV, and HCV NCEs.
Allison LaHood (13149567), Mike Frick (9395889), Rifat Rahman (4093138), Carole D. Mitnick (8385144), Lindsay McKenna (9395886)   +4 more
core   +1 more source

Pharmacovigilance in Action: Utilizing VigiBase Data to Improve Clozapine Safety

Patient Preference and Adherence
Carlos De las Cuevas,1 Emilio J Sanz,2,3 Jose de Leon4,5 1Department of Internal Medicine, Dermatology, and Psychiatry and Instituto Universitario de Neurociencia (IUNE), Universidad de La Laguna, La Laguna, Canary Islands, Spain; 2Department of Physical
De las Cuevas C, Sanz EJ, de Leon J
doaj  

Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence

BMJ Open
Objectives To compare the premarket and postmarket evidence of safety and efficacy of direct oral anticoagulants approved for stroke prevention in atrial fibrillation patients across four major regulatory agencies.Design Cross-sectional.Setting European ...
Joseph S Ross, Tianna Zhou, Maryam Mooghali   +2 more
doaj   +1 more source

Progress in Natural Products Target Discovery Technology

MedComm, Volume 7, Issue 6, June 2026.
Here, we provide a comprehensive overview of current technologies and recent advancements in therapeutic target discovery for natural products. By systematically synthesizing the principles, methodologies, and practical applications of existing experimental and computational strategies, this work provides a more actionable reference framework for ...
Qiyuan Pan, Xiao Yuan, Jinmei Jin, Xin Luan, Cheng Luo, Hongzhuan Chen, Weidong Zhang, Hao Zhang   +7 more
wiley   +1 more source

2024 update on postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia

Introduction Considering lack of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions (AEs) to secure a ...
Niki Katsiki, Dan Gaita, Carlos Escobar, Zeljko Reiner, Arrigo F.G. Cicero, Federica Fogacci, Daniel Pella, Gustavs Latkovskis, Peter E. Penson, Maciej Banach   +9 more
core   +1 more source

Forest plot of the odds ratio of OGIB detection in the premarketing and postmarketing settings.

, 2016
A: Premarketing setting. B: Postmarketing setting.
Mitsuo Umezu (804421), Kazuo Iijima (2818318), Kiyotaka Iwasaki (2818321)   +2 more
core   +1 more source

Effect of Capsaicin (8%) Topical System on Sensory Function in Patients With Diabetic Peripheral Neuropathy: Analysis of the PACE Study

Muscle &Nerve, Volume 73, Issue 6, Page 1109-1117, June 2026.
This graphical abstract provides a summary of the analysis of the PACE study that evaluated the effect of high‐concentration capsaicin topical system (HCCTS) on sensory function in patients with DPN. From left to right: Progression of untreated DPN; Research question for current analysis; Outcomes used to evaluate sensory function; Intervention; Main ...
Nathaniel P. Katz, Sam Allen, Audrey Carnevale, Lizandra Marcondes, David M. Simpson   +4 more
wiley   +1 more source

Post-marketing stability surveillance: Amoxicillin

South African Family Practice, 2006
Background: To ensure the successful treatment of infectious disease using antimicrobial therapy, a sufficient concentration of the stable, active drug is required at the site of infection.
K.K. Naidoo, P. Nompuku, S.N. Mkalali, K. Shabangu, L. Nkabinde, V. Singh   +5 more
doaj   +1 more source