OBJECTIVE to elaborate and apply a method to assess the efficacy of automated flexible endoscope reprocessors at a time when there is not an official method or trained laboratories to comply with the requirements described in specific standards for this type of health product in Brazil. METHOD the present methodological study was developed based on the following theoretical references: Intern...

Introduction: There have been significant advancements in the treatment of cystic fibrosis (CF), particularly for people who are eligible CFTR modulators drugs. However, there is an unequal access to these drugs worldwide. Currently, Brazil, only Ivacaftor approved public health system. The state Bahia, located Northeast presents a highly admixture population. In spite this F508del variant most...

Aims: To reflect on the impact of self-medication in times pandemic COVID-19 for patients undergoing treatment breast or prostate cancer.
 Study Design: this is a reflective study with qualitative approach based documentary analysis package inserts issued by ANVISA manufacturers analyzed drugs.
 Place and Duration Study: Integrated Health Research Laboratory from UFRJ-Macaé Multidisci...

Background: Spinal muscular atrophy (SMA) is an autosomal-recessive disorder resulting in progressive muscle weakness. In August 2017, the Agência Nacional de Vigilância Sanitária (ANVISA) approved first treatment for SMA, a drug named nusinersen that administered intrathecally. However, many patients with SMA have neuromuscular scoliosis or spinal instrumentation challenging intrathecal access...

Regulatory Impact Analysis, which is recommended to regulatory departments, aims to improve regulatory quality by providing information about the costs and benefits of regulation as well as solutions to current issues to enhance the decision-making process. This article discusses the importance of Regulatory Impact Analysis in the context of the National Agency for Sanitary Surveillance perform...