OPDP, Lilly Come to Terms Over TV Ads for Migraine Drug

OPDP, Lilly Come to Terms Over TV Ads for Migraine Drug

In its final Untitled Letter of 2021, FDA’s OPDP cited Eli Lilly for omission of risk information in two TV ads for EMGALITY®, but the company’s response seems to have resolved the issue, a Jan. 12 OPDP closeout letter states...

 

January 17, 2022 4:37 PM

Omicron Causes FDA Suspension of Most U.S. Inspections Through Jan. 19

Omicron Causes FDA Suspension of Most U.S. Inspections Through Jan. 19

The FDA’s ability to catch up with its inspection backlog caused by the COVID-19 pandemic is slowing again after omicron risks caused the agency to postpone many inspectional activities through Jan. 19...

January 10, 2022 8:20 PM

CDER, CBER Approve Total of 60 New Products in 2021, Despite Challenges

CDER, CBER Approve Total of 60 New Products in 2021, Despite Challenges

2021 was a year of many healthcare challenges, but against this backdrop the FDA approved 50 novel drugs and 10 biological license applications...

January 4, 2022 8:34 AM

CDER Steps in to Issue Warning Letters for Vaping Products Deemed Drugs

CDER Steps in to Issue Warning Letters for Vaping Products Deemed Drugs

Recent FDA Warning Letters calling out promotional claims made about vaping products are interesting in that they were issued not by the agency’s Center for Tobacco Products, but by CDER...

December 13, 2021 4:03 PM

Upcoming Event

{title}

{body}

Read More +

About Us

CHC

CHC

The Coalition for Healthcare Communication is an organization that promotes the free exchange of scientific and medical information. It is essential that healthcare professionals and the general public receive truthful, accurate information regarding pharmaceuticals, medical products and devices, and patient care.

In addition to white papers and other documents published by the Coalition, you can also find relevant information on current healthcare and health economics issues, as well as policy positions published by government agencies and other professional organizations.