Meditrial Editorial Team2024-02-26T10:57:19+00:00April 21st, 2020|Categories: Compliance, Covid-19, Regulatory, USA|Tags: Covid-19, FDA, USA|
FDA issued indications for medical device manufacturers within the CARES Act: Coronavirus Aid, Relief, and Economic Security Act. General provisions Medical device manufacturers are now required to report permanent discontinuance or interruption in manufacturing for the following categories of [...]
Meditrial Editorial Team2024-02-26T16:52:20+00:00April 17th, 2020|Categories: Compliance, Covid-19, Europe, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) issued a guidance temporarily allowing postponement or remote audits of medical device manufacturers necessary for the re-certification of CE marking and related requirements. Normally, manufacturers must undergo on-site audits by Notified [...]
Meditrial Editorial Team2024-02-07T16:10:56+00:00April 17th, 2020|Categories: Clinical Trial, Compliance, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, USA|
The FDA has posted a new “At-a-Glance Summary” that captures the agency’s major activities in the fight against COVID-19. The FDA has made a wide range of information regarding their activities available to the public on their COVID19 website. [...]
k.janecek2024-02-01T16:43:42+00:00April 15th, 2020|Categories: Clinical Trial, Compliance, Covid-19, Regulatory|Tags: Clinical Trial, Columbia, Covid-19, Regulatory|
In accordance with the provisions of Resolution No. 2020012926 of April 3, 2020 "By means of which temporary administrative measures are adopted within the framework of the health emergency declared by the National Government due to COVID-19" , it [...]
k.janecek2024-02-26T11:12:52+00:00March 27th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, Western Europe|Tags: Clinical Trial, Covid-19, Europe, Regulatory|
On March 26, 2020, the BfArM published "Additional recommendations on the European Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic " for clinical trials with medicinal products. All recommendations are aimed at: continue to ensure [...]
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