Feb 10, 2021 | News, Regulatory
Pfizer announced that it was withdrawing its application for emergency use authorization (EUA) in India for its COVID-19 vaccine. The pharmaceutical company failed to meet India’s regulatory requirements for a local immunogenicity study to ensure the safety of the...
Jun 15, 2020 | Medical Writing
Dr. Nimita Limaye returns to continue answering our guest audience questions in regards to authoring a clinical study protocol! This week, she explains the importance of protocol synopsis and ensuring the completeness of the protocol, as well as defines crowdsourcing...