SQA Regulatory Surveillance Summary | July 2020
By Laurel Hacche and Debra Cortner, SQA Associates European Medicines Agenda (EMA) Parenteral Drug Association (PDA) News – EMA: Final Assessment Report on Nitrosamines, 22 July 2020 The Committee for Medicinal Products for Human Use (CHMP) of the EMA published a final assessment report on nitrosamine impurities on 25 June 2020. The report calls on […]
Regulatory Surveillance Summary | May 2020
By Laurel Hacche and Debra Cortner, SQA Associates Health Canada Regulations and Guidances Health Canada Announces Another Step to Accelerate Access to Health Products for COVID-19, 27 May 2020 The COVID-19 pandemic has led to a global search for therapies to treat, diagnose, mitigate, or prevent the infection. Before new therapies can be made available […]