FDA Issues Draft Guidance and 510(k) Submission Checklist
On August 13, 2012, the U.S. Food and Drug Administration (“FDA“) issued a Draft Guidance document entitled “Refuse to Accept … Learn More
On August 13, 2012, the U.S. Food and Drug Administration (“FDA“) issued a Draft Guidance document entitled “Refuse to Accept … Learn More
As we have previously reported here and here, manufacturers of conventional food products and dietary supplements have often been the … Learn More
Establishments involved in the production and distribution of medical devices intended for use in the United States are required to … Learn More
On August 16, 2012, the Federal Trade Commission (“FTC“) announced a proposed settlement with the mouthguard marketer Brain-Pad, Inc. (“BPI”). … Learn More
The recent nationwide outbreak of fungal meningitis has pushed compounding pharmacies back into the public spotlight. The cases of fungal … Learn More
On October 3, 2012, two companies and 11 individuals of an alleged Russian military procurement network operating in the United … Learn More
On October 3, 2012, Judge Lewis A Kaplan of the United States District Court for the Southern District of New … Learn More
Introduction As the price of healthcare continues to increase, healthcare practitioners have become more innovative and creative in their attempts … Learn More
The U.S. Food and Drug Administration (FDA), in partnership with multiple international regulatory and law enforcement agencies, targeted over 4,100 … Learn More
The safety hazards of texting or emailing while driving are obvious. Potentially fatal repercussions await such callous and indifferent texters, … Learn More