In December of 2021, the FDA released a Draft Guidance document on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” Clinical trials may...
Read The ArticleOn December 9, 2021, the U.S. Food and Drug Administration (FDA) released draft guidance entitled “Considerations for the Use of Real-World Data and Real-World Evidence...
Read The Article“What CITI Program is Reading” is our weekly blog series which highlights news articles curated by our staff and relevant to research, higher education, healthcare,...
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Read The ArticleIn October 2021, the National Institutes of Health (NIH) announced the launch of the Bespoke Gene Therapy Consortium (BGTC), part of their Accelerating Medicines Partnership...
Read The Article“What CITI Program is Reading” is our weekly blog series which highlights news articles curated by our staff and relevant to research, higher education, healthcare,...
Read The ArticleOn January 31, 2022, the new European Medicines Agency (EMA) Clinical Trials Regulation (Regulation (EU) No 536 / 2014) comes into effect according to the...
Read The ArticleAs of January 2, 2022, institutions will be required to submit OHRP incident reports, electronically, via the new online form (unless they are unable to...
Read The ArticleMITRE and the Medical Device Innovation Consortium (MDIC), with funding by the U.S. Food and Drug Administration (FDA), has released “Playbook for Threat Modeling Medical...
Read The Article“What CITI Program is Reading” is our weekly blog series which highlights news articles curated by our staff and relevant to research, higher education, healthcare,...
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