Healthcare Packaging4h
FDA Warning Letters: The Do's and Don'ts on How to Respond
Do: Respond within 15 business days of the original letter and be specific in that response. “It’s important to critically ...
JD Supra22h
FDA Debuts a New Communications and Compliance Tool for Device Data Integrity Concerns
Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...
STAT1d
Study reveals how often medical device makers report safety incidents late to FDA
Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a ...
JD Supra1d
Reminder: FDA Does, In Fact, Review DOF
FDA took issue with the promotional communication presented in an exhibit booth panel (“panel”) [2] for Hemady ®, a drug indicated in combination with other anti-myeloma products for the treatment of ...
Kennedy asks FDA to revise 'self-affirm' rule for food ingredient safety
U.S. Secretary of Health and Human Services Robert Kennedy Jr. directed the Food and Drug Administration on Monday to revise ...
Drug Delivery Business3d
Dexcom receives FDA warning letter
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
MedTech Dive4d
Dexcom receives warning letter based on FDA inspections of 2 plants
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
KFF Health News4d
How the FDA Opens the Door to Risky Chemicals in America’s Food Supply
The FDA has relied on food companies for decades to determine whether their ingredients are safe. Some chemicals and ...
National Law Review4d
FDA Issues FSVP-Related Warning Letters
Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at ...
Dexcom receives FDA warning letter for two U.S. manufacturing facilities
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
Time14d
‘We Were Told Nothing.’ What to Know About the Canceled Meeting to Discuss the Next Flu Shot
In the late afternoon of Feb. 26, members of the U.S. Food and Drug Administration (FDA)'s expert committee on vaccines received an unusual email. It informed them that their upcoming meeting on ...