Health Reform
177 views

How crazy is Ted Cruz’s FDA reform proposal?

DavidEWilliams - January 4, 2016

I don’t think very highly of Senator and Republican Presidential candidate Ted Cruz, but his proposal to loosen the drug approval process is at least worth discussing.…

Gadzooks!  There’s Gluten in my Cheerios!
Policy & Law
200 views
Policy & Law
200 views

Gadzooks! There’s Gluten in my Cheerios!

Michael Kirsch - November 17, 2015

Gluten is in the news again.  Gluten and probiotics are among the two dietary issues that most consume my patients.  I am asked for my opinion on…

Business
1198 views

In Praise of FDA Collaboration: The Cardiac Safety Example

DavidEWilliams - December 18, 2014

The Food and Drug Administration gets a lot of grief. Some think the FDA is too restrictive, keeping useful drugs and devices off the market and thus harming patients.…

Social Media and FDA Regulation for Medical Devices
Business
186 views
Business
186 views

Social Media and FDA Regulation for Medical Devices

Jonathan Catley - October 10, 2014

When marketers use the term “social media,” most people immediately think of Facebook and Twitter. While these platforms have certainly proven beneficial in generating interest in many…

Michael Little Offers Insights on FDA’s 2014 Regulations for LDTs
Policy & Law
152 views
Policy & Law
152 views

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

Kenneth Walz - August 19, 2014

On July 31, 2014, the U.S. Food and Drug Administration announced its plans for regulation aimed at ensuring that certain tests used by healthcare professionals provide accurate,…

Business
157 views

CLL and Lymphoma Drug Approvals: Kudos to the FDA

Andrew Schorr - July 30, 2014

Dr. Richard Pazdur, director of the Food and Drug Administration’s cancer drug officeI gotta be fair to Dr. Dr. Richard Pazdur, director of the Food and Drug…

Business
148 views

FDA Social Media Guidance: Hangout on Air

David Harlow - July 29, 2014

Last month, the FDA released draft guidance on social media and internet platforms with character space limitations and a separate draft guidance for correcting misinformation posted online.…

FDA Offers Guidance on Social Media Etiquette for Medical Device Manufacturers
eHealth
186 views
eHealth
186 views

FDA Offers Guidance on Social Media Etiquette for Medical Device Manufacturers

Jonathan Catley - July 4, 2014

On June 18, 2014, the US Food and Drug Administration (FDA) released draft guidelines regarding how medical device manufacturers could use social media, Twitter, and other space-limited…

Double Trouble: Two New FDA Draft Guidances on Social Media
Social Media
194 views
Social Media
194 views

Double Trouble: Two New FDA Draft Guidances on Social Media

Chen Sirkis - June 20, 2014

   Two NEW FDA DRAFT Guidances On the Use of Social Media and Online Promotions of Devices and DrugsAfter five years in the making, the FDA is…

Business
113 views

FDA Releases Draft Social Media Guidance 5 Years After Public Hearing

David Harlow - June 18, 2014

Five years after its most recent public hearing on the subject of social media marketing of drugs and medical devices, the FDA released a draft