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Regulatory Updates

 

Type of Publication
Title Format Date Author
Regulatory Update Enhancing Protections for Research Subjects & Reducing Burden, Delay, and Ambiguity for Investigators PDF 01/18/13 ClinicalRM
A review of the Proposed Rulemaking by the Department of Health & Human Services for Human Subject Research Protections.

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Regulatory Update Overview of the Guidance Q&A on Informed Consent Elements PDF 10/29/12 ClinicalRM
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 The FDA & The New 501(k) Action Plan PDF 6/01/11 ClinicalRM
  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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