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FDA Creates Biosimilars Toolkit For Health Care Degree Programs

The FDA’s Center for Drug Evaluation and Research’s Office of Therapeutic Biologics and Biosimilars (OTBB) has created curriculum materials to help educators improve understanding about...

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What CITI Program is Reading – January 11, 2022

“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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OSTP Releases Guidance on National Security for U.S. Government-Supported Research

On January 4, 2022, the White House Office of Science and Technology Policy (OSTP) released the report, “Guidance for Implementing National Security Presidential Memorandum 33...

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FDA Releases Draft Guidance on Digital Health Technologies & Remote Clinical Investigations

In December of 2021, the FDA released a Draft Guidance document on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.”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...

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FDA Releases Draft Guidance on Real-World Evidence (RWE) in Clinical Trials

On December 9, 2021, the U.S. Food and Drug Administration (FDA) released draft guidance entitled “Considerations for the Use of Real-World Data and Real-World Evidence...

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What CITI Program is Reading – December 14, 2021

“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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CITI Program’s December 2021 Media Playlist – Part 2

CITI Program’s media playlists highlight content curated by our staff and relevant to research, higher education, healthcare, technology, and more. Follow us on LinkedIn for...

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Gene Therapy Consortium Launches

In October 2021, the National Institutes of Health (NIH) announced the launch of the Bespoke Gene Therapy Consortium (BGTC), part of their Accelerating Medicines Partnership...

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What CITI Program is Reading – December 7, 2021

“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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(EU) No 536/2014 Regulation Comes into Application in January 2022

On January 31, 2022, the new European Medicines Agency (EMA) Clinical Trials Regulation (Regulation (EU) No 536 / 2014) comes into effect according to the...

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