ANVISA Intensifies Monitoring of Generic Drugs: New Requirements in Force
The National Health Surveillance Agency (Anvisa) recently announced a new package of regulatory measures aimed at strengthening the monitoring of generic drugs in Brazil. The aim is to ensure even greater safety and efficacy for these products, which are widely used by the population and represent a significant part of the national pharmaceutical market.
FDA publishes product-specific guidances to facilitate generic drug development
FDA publishes product-specific guidance’s to facilitate generic drug development.
Registration of Generic Drug Registration (ANDA) with the US FDA
Drug companies must submit an abbreviated new drug application (ANDA) to FDA for approval to market a generic drug.