This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment

EMA updated Guidance on the Management of Clinical Trials During the COVID-19 (CORONAVIRUS) Pandemic.

EMA updated Guidance on the Management of Clinical Trials During the COVID-19 (CORONAVIRUS) Pandemic.

The biosimilar study is conducted comparing Ritonavir and Lopinavir combination (Kaletra) against biosimilar candidate Orvical. Kaletra was approved against HIV.

The biosimilar study is conducted comparing Ritonavir and Lopinavir combination (Kaletra) against biosimilar candidate Orvical. Kaletra was approved against HIV.

Due to COVID-19, the implementation of MDR in Europe that was scheduled for 2020 will be postponed to 2021.

Due to COVID-19, the implementation of MDR in Europe that was scheduled for 2020 will be postponed to 2021.

The U.S. Food and Drug Administration added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” This guidance is intended for industry, investigators, and institutional review boards.

The U.S. Food and Drug Administration added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” This guidance is intended for industry, investigators, and institutional review boards.

You can find several guidelines on Vaccine Development on our Internet site.