Risk mitigation plans (RMP) are an innovative and important strategy for monitoring the sanitary risks of medication. The scope of the study was to identify RMPs for drugs registered with the Food and Drug Administration (FDA) and the actions to minimize risks established by the Brazilian Health Surveillance Agency (Anvisa) and the manufacturers of these drugs. This is a quantitative and descri...

Developing countries have experienced a dramatic increase in the number of clinical studies in the last decades. The aim of this study was to describe 1) the number of clinical trials submitted to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, Anvisa) from 2007 to 2012 and the number of human-subject research projects approved by research ethics committees (...

The regulation of medication advertising in Brazil has four weak points. Inspection and punishment of irregularities is carried out a posteriori to the infraction being committed (when the population has already been exposed to a sanitary risk). The fines charged by the Brazilian Sanitary Surveillance Agency (Anvisa) have a derisory value compared to investments in advertising. There is no mech...

This paper presents an analysis on drug advertising in Brazil, based on the final report of the MonitorACAO Project, by the group from the Universidade Federal Fluminense, Niterói, Rio de Janeiro. Due to a partnership between the university and the National Agency for Health Surveillance (ANVISA), drug advertisements were monitored and analyzed for one year, according to the methodology defined...

A questão que norteou este estudo é a compreensão do papel da agência reguladora brasileira, Agência Nacional de Vigilância Sanitária (ANVISA) como promotora desenvolvimento tecnológico e inovação para além sua principal atividade agente regulador. O econômico está atrelado ao social, são elementos sinalizam necessidade Estado neste caracterizado pela ANVISA. Foi escolhido o recorte medicamento...

BACKGROUND Knowing the phenylalanine (Phe) content of foods is essential for managing the diet of patients with phenylketonuria. Data on the Phe content of foods are scarce and sometimes vary between different Food Composition Tables (FCT). Brazil created its own table of the Phe contents of fruits and vegetables based exclusively on the chemical analysis of protein content, considering that pr...

Submit Manuscript | http://medcraveonline.com Abbreviations: ANVISA: National Health Surveillance Agency; BHA: mixture of 2-tert-butyl-4-hydroxyanisole and 3-tert-butyl4-hydroxyanisole; BHT: 3,5-di-tert-butyl-4-hydroxytoluene; CGMS: Gaseous Chromatography coupled to Mass Spectrometry; HPLC: High Pressure Liquid Chromatography; PG: Propyl 3,4,5-trihydroxybenzoate or Propyl Gallate; TBHQ: Tertbut...