Anvisa Authorizes the immediate and emergency use of 24,000 units of Monkeypox diagnostic reagents, comprising two molecular kits produced by BioManguinhos/Fiocruz.
Anvisa approves release of vaccine and medicine against monkey pox
Before reaching the Brazilian consumer market, it is necessary that a drug has its quality, safety, and therapeutic efficacy evaluated by the National Health Surveillance Agency (ANVISA).
The new indication is for adult patients who do not require supplemental oxygen and who are at risk of progressing to a severe case.
Fiocruz, through its Genomics Network, has concluded the genetic sequencing of the monkeypox virus (MPXV) collected from a sample coming from Rio de Janeiro.
The National Health Surveillance Agency (Anvisa) provides guidance on prevention and mitigation measures for Monkeypox in hospitals, clinics and other health services that provide care to suspected and confirmed cases of the disease.
The National Health Surveillance Agency (Anvisa) is asking for reinforcement of non-pharmacological measures, such as distancing, use of masks and frequent hand hygiene, in airports and aircrafts, to delay the entry of the monkey pox virus into Brazil.
On March 8, 2022 Brazil’s Anvisa and the U.S. Food and Drug Administration (FDA) have signed a Cooperation Statement aimed at maintaining and strengthening their collaboration mechanisms.
Overview FDA facilitates the management of post approval CMC to harmonize regulatory approval of drugs with ICH Q12 guideline. This guidance applies to pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorization and to drug-device combination products that meet the definition of a pharmaceutical or biological product. Regulatory tools and […]
On January 18th 2021, the US Food and Drug Administration (FDA) released a five-part action plan for their artificial intelligence and machine learning (AI/ML) software and classified it as a medical device (SaMD).
On December 28, 2020 , the U.S. Food and Drug Administration ( FDA) announced the rates for over the counter (OTC) monograph drug user fees for fiscal year (FY) 2021.
US FDA releases draft guidance for Cannabis and Cannabis- derived Compounds used in Clinical Research
The US FDA released a new guidance on July 2020 on the clinical research and development of drugs containing cannabis or cannabis derived compounds.