NEWS

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.

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

An article in Nature Reviews Drug Discovery summarizes the latest advances in vaccine development against COVID-19. There are 78 candidates and 5 of them are on clinical trial now.

ISAC (International Society of Antimicrobial Chemotherapy) declared that there are serious problems in the study published in IJAA by Dr. Gautret titled "Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial".

You can find documents, guidelines, reports and other information in Clinical Research Association COVID-19 Information Area..

UNESCO prepared a paper on "Statement on COVID-19: Ethical Considerations from a Global Perspective".

FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP). It uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.

JAMA published an article on Preserving Clinical Trial Integrity During the Coronavirus Pandemic.

On 18 March 2020 teleconference of global regulators convened jointly by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) under the auspices of the International Coalition of Medicines Regulatory Authorities (ICMRA)