The Bio Conference and the FDA Survey

The BIO conference was held last week in the wonderful city of Chicago.  A lot of people have been writing about it.  So I decided to join in.  The blog On Pharma has some very nice daily updates.  Former President Clinton was there.  It seems everyone who was anyone attended.  I did not go.

But – one of the many items of news, and there were a lot of them, that came out of the conference, caught my eye at On Pharma.  So with my hat off to them for bringing it up, I want to echo their posting on a matter to provide it with further circulation.

BIOCOM and Price Waterhouse have been conducting a survey since 1995 on the Working Relationship Between the Life Sciences Industry and the FDA.  According to the survey site, and this is quoted –

  • Part I: asks for general information concerning respondents company and opinions on various regulatory issues
  • Part II: consists of questions specific for submissions that were recently or are currently being reviewed by the FDA
  • Part IIA: Pharmaceuticals
  • Part IIB: Biologics
  • Part IIC: Medical Devices and/or In Vitro Diagnostics

"The information provided by your company will be held in strictest confidence and analyzed only by PricewaterhouseCoopers LLP staff. For reporting purposes, information will be aggregated, further ensuring anonymity of your submittal."

J0302919 So, this is your chance to tell them what you think and what kind of experiences you have had when interacting with FDA.  I have seen some very uneven responses in the way the agency has approached some issues in which I have been involved and this has been sometimes very discouraging.  If you have had such experiences, here is a chance to provide feedback.  These results are shared with the FDA and with Congress.  Ok, it doesn’t sound as exciting as the work Price Waterhouse may do on the Academy Awards, but still…. If you are interested in answering the survey, click here

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