Court orders FDA action on antibiotic use on farms - USATODAY.com:
"In a ruling handed down Thursday, Judge Theodore Katz said the FDA must begin steps to withdraw approval of the two antibiotics for routine use in animals, siding with four consumer safety groups that brought a lawsuit against the agency.
"Today we take a long overdue step toward ensuring that we preserve these lifesaving medicines for those who need them most — people," said Avinash Kar, attorney for the Natural Resources Defense Council.
The court ruling will not immediately halt the use of antibiotics on farms. The FDA must first give drug companies a chance to respond and schedule a public hearing."
'via Blog this'
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FDA - Animal and Veterinary - Antimicrobial Resistance
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Saturday, March 24, 2012
Court orders FDA action on antibiotic use on farms
Wednesday, May 27, 2009
Drugs - Devices - Preemption - Explained Clearly
My hat is off to Matt Hotz, on the Pharma Compliance Blog, for writing this succinct and consumable post that even I can understand, Preemption and the Distinction between Drugs and Devices. I'm not a lawyer, so I've found this particular topic difficult to digest. Hotz' post got me up to speed quickly and expanded my understanding of the touchpoints to local, state, vs. federal law; and to the distinctions and nuances between drugs vs. medical devices. Now I feel that I can follow breaking preemption news with some basic foundational understanding. Thanks Matt!
Monday, April 13, 2009
The Medical Device Safety Act of 2009
It's a firestorm! The FDA announced that makers of certain older and risky medical devices will have to prove that their products are safe and effective according to the New York Times. This is a very hot issue. Related to this, I just read an editorial published by NEJM (the New England Journal of Medicine): The Medical Device Safety Act of 2009. Who's side are you on? The patient? Industry? Litigation attorneys? Others?
Saturday, February 21, 2009
Court Says MMR Vaccine Not A Cause of Autism (video)
A special court's recent ruling that no proven link exists between autism and certain early childhood vaccines seems to have done little to change the sometimes-passionate opinion fueling the debate. The panel of "special masters" ruled that these petitioners had not presented sufficient evidence to prove that the childhood vaccines (specifically the measles-mumps-rubella vaccine containing thimerosal, a mercury-based preservative) caused autism in their children. Learn more about this court ruling in this ABC News Video report, WATCH: Ruling on Autism and Vaccines.
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