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The legislation would give federal officials more flexibility in evaluating the effectiveness and safety of drugs and devices and add billions of dollars to NIH funding. But critics say it could endanger patients’ safety and doesn’t do enough to stop spiraling drug prices.
The FDA’s drug-approval team is short more than 700 people and losing skilled staff members to the drug industry.
The agency found several prominent facilities had not followed rules on reporting incidents in which patients were harmed.
Pricey and unproven therapies that sound too good to be true probably are.
A voucher awarded to companies that find treatments for rare childhood diseases can be sold to the highest bidder — and then used to speed up approvals for much more common drugs.
Researchers examine the Food and Drug Administration’s “revolving door” regarding employees who worked on cancer and hematology drugs.
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 formulas 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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