Results 11 to 20 of about 49,725 (243)
A Brief Report on Proposed Areas of International Harmonization of Real-World Evidence Relevance, Reliability and Quality Standards Among Medical Product Regulators. [PDF]
Pharmacoepidemiol Drug SafABSTRACT Background International harmonization of real‐world data and evidence (RWD/E) standards is a goal among real‐world data/real‐world evidence (RWD/E) policy stakeholders. The Duke‐Robert J. Margolis Institute for Health Policy developed an online ‘International Harmonization of RWE Standards Dashboard’ to provide timely updates around these ...
Nafie M +3 more
europepmc +2 more sources
Nonconformities in clinical laboratories in Macapá, Amapá, Brazil, based on the RDC no. 302/2005/Anvisa [PDF]
Jornal Brasileiro de Patologia e Medicina Laboratorial, 2020 ABSTRACT Introduction: Clinical analysis laboratories are health care facilities that provide resources for outpatient and/or emergency diagnoses; they are regulated in Brazil by the Resolution of the Collegiate Board of Directors (RDC) no. 302, of October 13, 2005, of the Brazilian National Agency of Sanitary Surveillance (Anvisa).
Madson Ralide Fonseca Gomes +9 more
openaire +4 more sources
Teoria E Cultura, 2020 O debate sobre a regulamentação do uso medicinal da Cannabis, assim como o cultivo para esse fim e as pesquisas científicas com a planta no Brasil, deu um novo passo com as consultas e audiências públicas 654 e 655 promovidas pela Anvisa ...
Ana Paula Lopes Da Silva Rodrigues
exaly +2 more sources
Temporal Trend in Selective Cyclooxygenase‐2 Inhibitors Sales in Brazilian Drugstores [PDF]
Pharmacoepidemiol Drug SafABSTRACT Purpose To assess the trends in selective cyclooxygenase‐2 inhibitor anti‐inflammatory drugs (coxibs) sales in Brazil from 2014 to 2021. Methods A time trend analysis of coxibs sales in Brazil from January 2014 to December 2021 was conducted using the Brazilian National Controlled Products Management System.
Biase T, Silva M, Lopes L, Galvao T.
europepmc +2 more sources
Pharmacopeia and ANVISA: A Necessary Symbiosis
Revista Brasileira de Farmácia Hospitalar e Serviços de Saúde, 2017 A basic principle supporting for the use of prescription drugs is the assurance of their quality, safety and efficacy. New drug products require double blind, multicentric randomized controlled clinical trials.
L. M. Lima
openaire +4 more sources
PLoS ONE, 2018 The circulation of poor quality medicines, especially in the developing countries, is a public health concern. Compliance with good manufacturing practices (GMP) is essential to ensure the quality, efficacy, and safety of medicines.
Andrea Renata Cornelio Geyer +2 more
exaly +2 more sources
MEDICAMENTOS ANTINEOPLÁSICOS E A ANVISA: O CASO LENALIDOMIDA
RAHIS, 2013 O processo de registro de novos medicamentos, especialmente os antineoplásicos, no Brasil é ainda uma tarefa complexa. A partir do estudo do caso Lenalidomida, discute-se os interesses das partes envolvidas (ANVISA, médicos, pacientes, associações de apoio, advogados, laboratórios farmacêuticos e empresas de pesquisa clínica) e como esses grupos ...
Marcos Roberto Píscopo +2 more
openalex +4 more sources
Regulatory issues related to the use of sodium hypochlorite solutions in endodontics. [PDF]
Int Endod JAbstract Aim To assess the regulation of sodium hypochlorite (NaOCl) solutions for endodontic usage in some of the world's main dental markets, in view of the European Union's recent move to classify antimicrobial root canal irrigants as high‐risk devices under their Medical Device Regulation (MDR).
Peters OA +7 more
europepmc +2 more sources
NANOMEDICAMENTOS E OS DESAFIOS DA ANVISA DIANTE DA INEXISTÊNCIA DE UM MARCO REGULATÓRIO NO BRASIL
, 2016 A nanotecnologia, em razao de suas propriedades singulares, pode proporcionar inumeros beneficios em diversas areas estrategicas: saude, eletronica, alimentacao, agricultura, meio ambiente entre outras. Um dos ramos mais promissores e o desenvolvimento e
Liziane Paixão Silva Oliveira +2 more
openalex +2 more sources
Anvisa e o controle do tabagismo
Revista de Direito Administrativo, 2015 .
Virgílio Afonso da Silva
openaire +3 more sources