In the first three years of the Trump administration, a grand total of 12 letters were sent by the FDA to drug makers warning them over violations found in their clinical drug trials. The agency’s warning letters are sent when the FDA notes violations of practice, procedure, or in some cases, law. In contrast, the first three years of the Obama presidency saw 99 such letters ...
Clinical Drug Trial Inspections Lacking Under Trump Administration
Posted October 31, 2020 in Drug and Medical Device Lawsuits | Product News and Recalls
Harley-Davidson Issues Recall Over Failing Clutches
Posted November 16, 2018 in Product News and Recalls
2018 has not been kind to Harley-Davidson. Less than one year after recalling close to 175,000 motorcycles because of potential of brake failure in certain circumstances, the iconic manufacturer has recalled almost 178,000 more over possible issues with the clutch used on the bikes.
The brake recall issued by Harley-Davidson in early 2018 was unique in that it was almost exclusively focused on owners who had allowed their brake fluid to ...
continue reading...Families Still Reeling in Aftermath of Contamination Findings Seen by Trump Administration as “PR Nightmare”
Posted September 20, 2018 in Camp Lejeune Water Contamination | Product News and Recalls
“I know that you can’t bring back three people that I lost, but they’re gone.” This is what retired airman Henry Betz had to say to federal officials during a recent “community engagement session.” The meetings; this one taking place in Horsham, Pennsylvania, are in response to recent revelations that groundwater used by military bases and their surrounding communities throughout the country was
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Think the FDA Has Your Best Interests in Mind? You May Want to Think Again.
Posted September 18, 2018 in Drug and Medical Device Lawsuits | Product News and Recalls
“Instead of a regulator and a regulated industry, we now have a partnership. That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.” This is the assessment of Dr. Michael Carome, director of health research for Public Citizen, on the current state of affairs at the Food and Drug Administration.
Earlier this summer, ProPublica published a damning look at the ...
continue reading...New Report Heightens Concerns Over Chemicals in Military Base Drinking Water
Posted July 6, 2018 in Camp Lejeune Water Contamination | Product News and Recalls
A report issued by the Agency for Toxic Substances and Disease Registry (ATSDR) concludes that so-called “safe” levels of chemicals found to be contaminating the water supplies around domestic military bases are one-tenth of the amount allowed by EPA guidelines. Concerns over the report’s conclusions were only amplified when it was revealed that; citing fears of a “PR nightmare,” the Trump White House and EPA ...
Citing PR “Nightmare,” Government Hides Report on Military Water Contamination
Posted July 2, 2018 in Camp Lejeune Water Contamination | Product News and Recalls
It has been one of the oldest, most overly-used tropes in the book. As the intended stewards of our nation’s natural resources, the Environmental Protection Agency has fought for decades against the notion that it puts owls over people; that it somehow values a small, previously unheard-of rodent over the potential impact of hundreds or thousands of jobs.
While the EPA’s regulations have put the brakes on ...
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