Tag: FDA

In Praise of FDA Collaboration: The Cardiac Safety Example

The Food and Drug Administration gets a lot of grief. Some think the FDA…

DavidEWilliams DavidEWilliams

Social Media and FDA Regulation for Medical Devices

When marketers use the term “social media,” most people immediately think of…

Jonathan Catley Jonathan Catley

Michael Little Offers Insights on FDA’s 2014 Regulations for LDTs

On July 31, 2014, the U.S. Food and Drug Administration announced its…

Kenneth Walz Kenneth Walz

CLL and Lymphoma Drug Approvals: Kudos to the FDA

Dr. Richard Pazdur, director of the Food and Drug Administration’s cancer drug…

Andrew Schorr Andrew Schorr

FDA Social Media Guidance: Hangout on Air

Last month, the FDA released draft guidance on social media and internet…

David Harlow David Harlow

FDA Offers Guidance on Social Media Etiquette for Medical Device Manufacturers

On June 18, 2014, the US Food and Drug Administration (FDA) released…

Jonathan Catley Jonathan Catley

Double Trouble: Two New FDA Draft Guidances on Social Media

   Two NEW FDA DRAFT Guidances On the Use of Social Media…

Chen Sirkis Chen Sirkis

FDA Releases Draft Social Media Guidance 5 Years After Public Hearing

Five years after its most recent public hearing on the subject of…

David Harlow David Harlow

FDA Perspective on Rare Diseases

Rich Moscicki, M.D., Deputy Center Director for Science Operations, FDA spoke to…

BioPharm Physicians BioPharm Physicians

FDASIA Health IT Report Issued

The FDA, the FCC and ONC issued a long-awaited joint report with…

David Harlow David Harlow