Posts Tagged ‘Drug’

Ethnographic Research and REMS

Monday, July 12th, 2010

-Guest Blog by Andrea J. Simon, PhD.-

In the past year, pressures to integrate observational or ethnographic research (which really are one and the same) in pharmaceutical and biotech industries are increasing as the value of this research is becoming better understood. In particular, Phase IV research involving the management and use of a drug protocol is becoming more and more important; i.e., when a drug is in widespread use, risks need to be better understood. At the same time, there is a growing sense of uncertainty around ethnography’s legitimate role, how to integrate it into quantitative research, and when to use its information and insights to support or alter a previously defined direction. Along with this greater scrutiny, there is rising debate about ‘best practices’ in observational research processes, especially regarding the need to define protocols to ensure that research is conducted with proper rigor and is producing suitable, credible results. (more…)

The REMS Sensitivity Index

Tuesday, March 23rd, 2010

Below is a qualitative index of the likelihood that FDA may require a REMS for a specific development compound as part of the NDA submission.

The presence of any attribute increases the probability of a REMS requirement; some items may be more highly weighted than others: (more…)

FDLI Conference on REMS: Benefits and Risks Meet Liabilities and Opportunities

Wednesday, February 24th, 2010

- Guest blog by Roger Morris, The LondonBritian Company -

You’ve heard all the analogies:  Is the glass half empty or half full?  Does the dark storm cloud have a silver lining?

I was constantly reminded of this during the Food & Drug Law Institute’s latest conference on REMS held February 16 in Washington, D.C., as the residents and transportation system was trying to dig out of one-two snowstorms.  It was an interesting conference, one that built substantially on the groundwork done at last year’s REMS conference which the FDLI co-hosted with ParagonRx. (more…)