Category Archives: Uncategorized

Draft Guidance on Unsolicited Requests for Off-Label Information

There has been a good deal of commentary on the recent issuance of a draft guidance by the FDA entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” which was issued by the agency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

DDMAC Enforcement Trickles

For some time there has been speculation that enforcement at FDA is up.  But it should be noted that regulatory action letters come from several different parts of the agency and encompass much more than promotional communications. For our purposes, … Continue reading

Posted in Uncategorized, Warning Letters | 2 Comments

Weekly Roundup 8-19-11

Hello?  Anyone out there?  I send out a group email and get back scores of automated replies thanking me for my email and telling me when the recipient will be back in the office.  I feel like the only person … Continue reading

Posted in Uncategorized, Weekly Roundup | 1 Comment

Financial Crisis = Public Health Crisis – FDA Funding

The mandate for protecting the public’s health at FDA has expanded dramatically, especially last year when the Food Safety Modernization Act (FSMA) was passed and signed into law, giving the FDA new authorities to inspect and initiate recalls of food … Continue reading

Posted in Uncategorized | 7 Comments

To Have and to Have Not – Is there an Emerging Digital Literati Divide in Medicine?

I was reminded as I tried to set up my new scale complete with WiFi that will feed into my iPad my weight, body mass index and with accompanying blood pressure cuff – my blood pressure.  The app in the … Continue reading

Posted in Uncategorized | 1 Comment