Merck submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).
About 75% of Merck’s comments that specifically address FDA’s questions is devoted to an argument in favor of…
AstraZeneca (AZ) submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).
Again and again throughout its comments to the FDA, AstraZeneca defends the concept that social media conversations…
For the past two years, Microsoft’s HealthVault group has been busily assembling a suite of personal medical devices that connect to its personal health information platform. Just this week the FDA’s top medical device reviewer, Donna-Bea Tillman, announced her plans…
Pfizer submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).
The world’s #1 pharmaceutical company stands alone in calling upon the FDA to develop new regulations for the…
Google submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).
The search giant devoted about 3 pages to defending Sidewiki, which presents users with a vertical window on…
PatientsLikeMe (PLM) — an online community for people with “life-changing conditions” — submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).
The most interesting comments are about…
I worked all weekend to submit to the FDA the results of the Pharma Marketing News/Blog survey of readers about FDA’s Regulation of Drug & Device Promotion via the Internet & Social Media.
As you may recall, the FDA asked…
The Continua Health Alliance, a consortium of more than 220 organizations working to enable interoperability between personal medical devices, noted in a recent newsletter that the FDA believes new laws for connected health device regulations are neither likely nor needed.…
By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C. “Under the Federal, Food, Drug, and Cosmetic Act, HIT software is a medical device.” That’s according to Dr. Jeff Shuren, the new director of the Device Center within FDA. Yikes.…
Internal FDA reports — part of a fierce debate within the agency over what to do about GSK’s Avandia — obtained by the New York Times, say that “if every diabetic now taking Avandia were instead given a similar pill…
