In Praise of FDA Collaboration: The Cardiac Safety Example
The Food and Drug Administration gets a lot of grief. Some think the FDA…
Social Media and FDA Regulation for Medical Devices
When marketers use the term “social media,” most people immediately think of…
Michael Little Offers Insights on FDA’s 2014 Regulations for LDTs
On July 31, 2014, the U.S. Food and Drug Administration announced its…
CLL and Lymphoma Drug Approvals: Kudos to the FDA
Dr. Richard Pazdur, director of the Food and Drug Administration’s cancer drug…
FDA Social Media Guidance: Hangout on Air
Last month, the FDA released draft guidance on social media and internet…
FDA Offers Guidance on Social Media Etiquette for Medical Device Manufacturers
On June 18, 2014, the US Food and Drug Administration (FDA) released…
Double Trouble: Two New FDA Draft Guidances on Social Media
Two NEW FDA DRAFT Guidances On the Use of Social Media…
FDA Releases Draft Social Media Guidance 5 Years After Public Hearing
Five years after its most recent public hearing on the subject of…
FDA Perspective on Rare Diseases
Rich Moscicki, M.D., Deputy Center Director for Science Operations, FDA spoke to…
