Entries from HEALTH LAW SECTION BLOG tagged with 'human subject protection'

FDAAA requirements update: drug safety, clinical trials database

A Draft Guidance for Industry about Medication Guides and REMS has been published for comment purposes (February 2011); the draft Guidance indicates that it is intended to address 2 topics pertaining to Medication Guides for drug and biological products-that...

HHS proposed new rules under HIPAA, privacy website

From HHS news-7/8/10-HHS Secretary Kathleen Sebelius announced important new rules and resources to strengthen the privacy of health information... (1)From the Joint Statement:[The] proposed regulations under HIPAA of 1996 would expand individuals’ rights to access their information and restrict certain...

OHRP's 2009 International Compilation of Human Subject Protections laws/regs/guidelines

The newly released 2009 edition of the International Compilation of Human Subject Protections (85 pp) is a compilation, prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services,designed for use by IRBs, researchers,...

FDA /CDERWarning Letters 2008-Bioresearch monitoring program

For purposes of thinking about trends, I found it interesting to take a look at the last 6 months of FDA/CDER Warning Letters resulting from inspections in regard to its Bioresearch Monitoring Program. The Warning Letters show recent and...

Update your CDER bearings

For more information on clinical investigators, protection of human subjects, and regulatory and compliance programs, a recent CDER news item sugggests CDER's "Information for Clinical Investigators" webpage. This webpage provides guidance for conducting clinical trials with investigational drugs and information...

Human Research Protections:impaired decision making capacity

Here's a copy of one recent FDA email alert of interest: Notice! The Office for Human Research Protections (OHRP), Office of Public Health and Science, is extending the public comment period for the previously announced REQUEST FOR INFORMATION ON RESEARCH...

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