The end of paper at Anvisa! Electronic Protocol is the future of Health Surveillance
The Brazilian Health Surveillance Agency (ANVISA) will fully adopt the electronic document protocol from March 13, 2025, as established by RDC 947/2024. This change will eliminate the need for paper documents, promoting greater agility in document analysis, modernizing processes and reducing operating costs, especially those related to digitization and physical storage.
RDC 954/2024 -Comprehending the Highlights and Impacts on Drug Registration
The National Health Surveillance Agency (ANVISA) has launched Collegiate Board Resolution, RDC 954/2024 introduces several updates to make the drug registration process more agile and in line with international standards. .
FDA Guidance on Substantial Evidence of Effectiveness for Drugs and Biologics
OVERVIEW Companies developing novel drugs or biologic products for rare diseases or other life-threatening diseases can now plan clinical studies for Investigational New Drugs (INDs) to establish their drug or biologic candidate’s effectiveness and explore strategies reduce to their time to market with New draft guidance from FDA. GUIDANCE: ‘Providing Evidence of Effectiveness of Human Drug […]