Regulatory News November
FDA issues draft guidance on “Benefit-Risk Assessment for New Drug and Biological Products”. “The intent of this guidance is to provide drug sponsors and other stakeholders with a clearer understanding of how considerations about a drug’s benefits, risks, and risk management options factor into certain FDA pre- and postmarket regulatory decisions about new drug applications (NDAs) submitted under the Federal Food, Drug and Cosmetic Act (FD&C Act) and biologics license applications” (Federal Register announcement).
EMA’s latest updates on COVID-19 vaccines and treatments. EMA’s recent communications on COVID-19 vaccines:
- Safety updates of COVID-19 vaccines
- EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG
- EMA starts rolling review of Evusheld (tixagevimab and cilgavimab) developed for the prevention of COVID-19 in adults
- EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19
- EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19 | European Medicines Agency (europa.eu)
Please check EMA’s dedicated webpage on COVID-19 for the latest updates.
EMA’s "Human Medicines Highlights" Newsletter. You can access the Newsletter by clicking here. Previous editions can also be found on this page.