Updates and regulatory news
Health Canada
What’s new in Biologics, radiopharmaceuticals and genetic therapies can be found at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radio-pharmaceuticals-genetic-therapies/what-new-biologics-radiopharmaceuticals-genetic-therapies-health-canada.html
Information for health product manufacturers and distributors in relation to COVID-19: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry.html
Health-related consultations: https://www.canada.ca/en/services/health/consultations.html
FDA
What’s new for Biologics including Approval and Determination Letters:https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics
COVID-19 Information and Resources:https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
Guidance Documents:https://www.fda.gov/regulatory-information/search-fda-guidance-documents
Upcoming Conferences:https://www.fda.gov/vaccines-blood-biologics/news-events-biologics
Updated Approvals and Listings:
Complete List of Licensed Products and Establishments
Complete List of Substantially Equivalent 510(k) Device Applications
Complete List of Currently Approved Premarket Approvals (PMAs)
Complete List of Currently Approved NDA and ANDA Application Submissions
2023 Biological Approvals
Guidance Documents CBER is Planning to Publish During Calendar Year 2023: https://www.fda.gov/media/120341/download