OR WAIT null SECS
October 02, 2020
A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.
Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.
The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.
October 01, 2020
Symbiosis has successfully completed a scheduled inspection by MHRA.
September 22, 2020
ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.
September 18, 2020
The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.
The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.
September 15, 2020
GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.
September 09, 2020
Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.
September 02, 2020
Despite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.