Monthly Archives: January 2012

Vacancies on FDA Advisory Committees

Anyone attending an FDA Advisory Committee meeting will likely discern right away that the job of serving in the capacity as a member is probably not terribly exciting.  You have to travel from where you live, review mountains of data, … Continue reading

Posted in Advisory Committee Prepapartion | 1 Comment

FDA Advisory Committee Action for 2012

As 2011 ended, there was a great deal of looking back at events of the year.  As it affected new medical products, FierceBiotech reported on Friday that drug approvals during the year increased to 30 last year. Now as we … Continue reading

Posted in Advisory Committee Prepapartion | 2 Comments

Weekly Roundup 1-6-12

It is the first Weekly Roundup of the new year and yet you would not think that to look at the garden where daffodil shoots have already appeared above the soil.  A petunia bloomed on the back deck on New … Continue reading

Posted in Weekly Roundup | Comments Off

Draft Guidance on Unsolicited Requests for Off-Label Information

There has been a good deal of commentary on the recent issuance of a draft guidance by the FDA entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” which was issued by the agency on … Continue reading

Posted in Uncategorized | 4 Comments

Personalized Risk Communication

Everyone has heard of the concept of personalized medicine – the idea that medicine can be steered to individuals who will be the most likely to benefit from it based on a number of factors, primarily genetic.  Personalized medicine involves … Continue reading

Posted in Risk Management | Comments Off