Does FTC Social Media Guidance Provide Clues for Pharma?
The pharmaceutical industry has yet to receive specific guidance from the U.S.…
Sequestration and Healthcare: What Organizations are Affected? (Part 1)
Summary: What does sequestration mean? What organizations are affected by the sequestration?What…
FDA Warning Letter: Don’t Make Unsubstantiated Claims, Even on Facebook
In December 2012, the FDA sent a warning letter to Amarc Enterprises…
Why New Standards Are Needed for Faster Cancer Drug Approvals
Several years ago I attended an FDA Oncology Drug Advisory Committee (ODAC)…
mHealth: Regulation vs. Innovation
In mid-February of this year, I wrote an article on Mobile Health…
A Consideration – Putting On the Brakes So We Can Move Faster…
by Kevin FickenscherKevin Fickenscher, MD, CEO AMIA by Kevin FickenscherKevin Fickenscher, MD,…
FDA Power Grab
As health-care providers computerize how they take care of us, we’re computerizing…
FDA Has a Good Idea; Doctors Object
The idea: In a move that could help the government trim its…
Mobile Health App Regulations: FDA & HIPAA
Mobile healthcare and apps, mHealth, is, at times, quite literally a matter…
How The Medical Device Industry Lobbies
30 Things You Need to Know About The Medical Device Industry…