Clinical Sciences - IRB Prereview

Fingerprint Dive into the research topics where Clinical Sciences - IRB Prereview is active. These topic labels come from the works of this organization's members. Together they form a unique fingerprint.

Investigational Drugs Chemical Compounds
United States Food and Drug Administration Medicine & Life Sciences
Research Personnel Medicine & Life Sciences
Investigational New Drug Application Medicine & Life Sciences
Vitamin E Medicine & Life Sciences
Endotoxins Medicine & Life Sciences
Cost-Benefit Analysis Medicine & Life Sciences
Retinopathy of Prematurity Medicine & Life Sciences

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Profiles

No photo of M E Blair Holbein
19832015

Research Output 1983 2015

13 Citations (Scopus)

Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

Holbein, M. E. B., Berglund, J. P., Weatherwax, K., Gerber, D. E. & Adamo, J. E., Oct 1 2015, In : Clinical and Translational Science. 8, 5, p. 526-532 7 p.

Research output: Contribution to journalArticle

Investigational Drugs
Legislation
Biological Factors
Pharmaceutical Preparations
Research Ethics Committees
1 Citation (Scopus)

Recommendations from the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award consortium: Developing and implementing a sponsor-investigators training program

Holbein, M. E. B., Berglund, J. P., O'Reilly, E. K., Hartman, K., Speicher, L. A., Adamo, J. E., O'Riordan, G., Brown, J. S. & Schuff, K. G., 2014, In : Journal of Investigative Medicine. 62, 5, p. 797-803 7 p.

Research output: Contribution to journalArticle

Investigational Drugs
Advisory Committees
Research Personnel
Education
Equipment and Supplies

Warning letters to sponsor- investigators at academic health centres - the regulatory "canaries in a coal mine"

O'Reilly, E. K., Holbein, M. E. B., Berglund, J. P., Parrish, A. B., Roth, M. T. & Burnett, B. K., 2013, In : Clinical and Investigative Medicine. 36, 6

Research output: Contribution to journalArticle

Canaries
Coal
United States Food and Drug Administration
Research Personnel
Health