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U.S. Rep. Ted Lieu (D-Calif.) renews his call for tightened laws that would force manufacturers to notify the Food and Drug Administration when they issue safety warnings in other countries related to the design and cleaning of their devices.
Newly released court documents show that after Tokyo-based Olympus Corp. alerted customers in Europe in 2013, it told its U.S. operation not to warn U.S. doctors and hospitals. Since then, at least 35 patients have died after being sickened in outbreaks.
Treatments marketed as everything from anti-aging applications to therapies for degenerative diseases are increasingly available at commercial clinics in the U.S., but their growing numbers raise ethical and regulatory concerns in the scientific community.
The Food and Drug Administration has introduced a simplified form that doctors will use to seek FDA approval to treat seriously ill patients with experimental drugs after other options run out.
But the authors caution against concluding that folic acid is ineffective.
After a wave of sometimes-deadly superbug infections, the agency last year ordered a recall of Custom Ultrasonics machines used to disinfect medical scopes. Now, with little explanation, it is backing off.
The FDA expands its purview over all tobacco products -- including e-cigarettes, cigars, pipe tobacco -- but the new regulatory process could permit many products sold in the U.S. to remain so for up to three years.
The problems persist even after Congress in 2012 gave the FDA enhanced powers to respond when drug levels are low.
Despite dozens of infections from medical scopes, an agreement on how to fix the FDA’s flawed regulation of the device industry remains elusive.
Versions sold that way are based on older 51ÊÓƵs and make tight control of blood sugar harder. But they are cheaper and might save the life of a diabetic patient whose alternative is to go without.
Nearly eight in 10 say they have seen or heard these ads, and more than a quarter have discussed one of the drugs with a physician as a result.
Essure has generated more than 5,000 complaints of serious side effects.
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