Regulatory Updates

Type of Publication Format Date Author
Regulatory Update PDF 01/18/13 ClinicalRM
Enhancing Protections for Research Subjects & Reducing Burden, Delay, and Ambiguity for Investigators

A review of the Proposed Rulemaking by the Department of Health & Human Services for Human Subject Research Protections.

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Regulatory Update PDF 10/29/12 ClinicalRM
Overview of the Guidance Q&A on Informed Consent Elements

Nanotechnology is defined as the manipulation of matter and structures at atomic and subatomic scales. Since the term was popularized by Eric Drexler in the early 80’s, nanotechnology has been used in products like cosmetics and sunscreens in passive form.

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Regulatory Update PDF 6/01/11 ClinicalRM
The FDA & The New 501(k) Action Plan

On January 19, 2011, the Director of the CDHR announced the development of new action plan for the 510(k) program. The following guidelines will be released periodically on a schedule over 2011.

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