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New FDA Guidance Provides Standards for Medical Device 510(k) Submissions

The U.S. Food and Drug Administration (FDA) issued a new guidance, entitled Electronic Submission Template for Medical Device 510(k) Submissions. 510(k) electronic submission requirements will...

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New FDA Draft Guidance on Ethical Considerations for Including and Protecting Children in Clinical Trials

The U.S. Food and Drug Administration (FDA) issued a new draft guidance, entitled Ethical Considerations for Clinical Investigations of Medical Products Involving Children. As a...

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On Campus Podcast – Accommodations in Online Learning

Season 1 – Episode 18: Accommodations in Online Learning The Americans with Disabilities Act (ADA) aims to make education more accessible for individuals with disabilities...

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Additional NIH Policy for Data Management and Sharing Resources

The National Institutes of Health (NIH) has released two new documents providing supplemental information to the NIH Policy for Data Management and Sharing (DMS). They...

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HIPAA Regulations and Implications for Your Institution

Since the Health Insurance Portability and Accountability Act (HIPAA) was signed into law in 1996, federal and state agencies have developed and refined privacy rules...

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Compare Federal Laws, Regulations, and Policies in Science and Security

The Council on Governmental Relations (COGR) has released version two of their research security comparison chart, summarizing and comparing federal laws, regulations, and policies. The...

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Presidential Order on Advancing Biotech and Biomanufacturing Innovation

The President of United States of America has issued an executive order to promote a sustainable, safe, and secure bioeconomy. Thirteen sections detail a wide-range...

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What CITI Program is Reading – September 20th, 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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CITI Program’s September 2022 Media Playlist – Part 1

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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How to Satisfy NSPM-33 Training Requirements

The National Security Presidential Memorandum 33 (NSPM-33) is an increasingly discussed topic in academia. The National Science and Technology Council’s (NTSC) Implementation Guide highlights four...

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