FDA Publishes ICH E8(R1) Guidance
The FDA has published the guidance document, “E8(R1) General Considerations for Clinical Studies,” to assist those that design clinical studies by outlining the internationally accepted...
Read The ArticleThe FDA has published the guidance document, “E8(R1) General Considerations for Clinical Studies,” to assist those that design clinical studies by outlining the internationally accepted...
Read The ArticleThe U.S. Food and Drug Administration (FDA) has resumed its unannounced foreign inspections program in India, yet it remains paused in China due to COVID-19...
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 ArticleThe Office for Human Research Protections (OHRP) recently released the guidance, “General Instructions on the Informed Consent Posting Requirement (45 CFR 46.116(h)).” The first of...
Read The ArticleThe U.S. National Library of Medicine has updated the Clinicaltrials.gov FAQs to address expanded access and all-cause mortality. The expanded access FAQs cover: What is...
Read The ArticleThe Office for Civil Rights (OCR) at the United States Department of Health and Human Services is seeking public input on recognized security practices as...
Read The ArticleAs a guest blogger for the NIH’s Under the Periscope blog, Dr. Mike Lauer, the NIH Deputy Director for Extramural Research, has introduced the NIH’s...
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 ArticleEvery year, the American Public Health Association organizes National Public Health Week (NPHW) not only to recognize contributions to public health, but to address important...
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