FDA Regulatory Update: FDA Commissioner Suggests that New LDT Regulations are Forthcoming; …
On June 2, 2013, U.S. Food and Drug Administration (“FDA”) Commissioner Margaret Hamburg delivered a speech at the American Society of Clinical ...
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Request for Comments on Risk-Based Regulatory Framework for Health IT
An interagency working group – composed of the Food and Drug Administration (FDA), Office of the National Coordinator for Health Information ...
Former HHS chief urges crackdown on compound pharmacies
Former Health and Human Services Secretary Tommy Thompson on Wednesday announced the formation of a working group to press for greater oversight of ...
Natura Pet Products Recalls Dog And Cat Food For Salmonella Contamination
A pet food recall has been issued by Natura Pet Products after six different brands of the company’s dog and cat food tested positive for Salmonella ...
Can new FDA graphic warning labels for tobacco pass a first amendment legal challenge?
When the FDA imposes new graphic warning labels for tobacco products, they can survive a First Amendment challenge if they depict health consequences ...
Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication
Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches.
Natura Pet Issues Voluntary Recall of Specialized Dry Pet Foods Due to a Possible Health Risk
Natura Pet Products is voluntarily recalling specific lots of dry pet food because it has the potential to be contaminated with Salmonella.
Toll reaches 118 in hepatitis A outbreak tied to frozen berry mix
At least 118 people in eight states are now sick with acute hepatitis A in an outbreak tied to a frozen berry mix widely sold at Costco stores.
FDA inspection finds a mess at pharmacy in second fungal outbreak
A Tennessee pharmacy believed to be the source of a second outbreak of fungal infections linked to pain shots was a mess when Food and Drug ...