Monthly Archives: January 2012

Vacancies on FDA Advisory Committees

Posted on January 11, 2012 by Mark Senak

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

Posted on January 10, 2012 by Mark Senak

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

Posted on January 6, 2012 by Mark Senak

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 →

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Draft Guidance on Unsolicited Requests for Off-Label Information

Posted on January 5, 2012 by Mark Senak

There has been a good deal of commentary on the recent issuance of a draft guidance by the FDA entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” which was issued by the agency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

Posted on January 4, 2012 by Mark Senak

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 →

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