FDA Faults 12 Hospitals For Failing To Disclose Injuries, Deaths Linked To Medical Devices
The agency found several prominent facilities had not followed rules on reporting incidents in which patients were harmed.
FDA
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Ask Emily
Beware Of Unapproved Stem Cell Treatments
Pricey and unproven therapies that sound too good to be true probably are.
By Emily Bazar -
The Orphan Drug Machine
A Golden Ticket That Fast-Tracks A Drug Through The FDA
A voucher awarded to companies that find treatments for rare childhood diseases can be sold to the highest bidder 鈥 and then used to speed up approvals for much more common drugs.
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When Drug Reviewers Leave The FDA, They Often Work For Pharma
Researchers examine the Food and Drug Administration鈥檚 鈥渞evolving door鈥 regarding employees who worked on cancer and hematology drugs.
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Congressman Decries Olympus’ Failure To Warn U.S. Hospitals About Tainted Scopes
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.
By Chad Terhune -
Olympus Told U.S. Executives No Broad Scope Warning Needed Despite Superbug Outbreaks
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.
By Chad Terhune -
American 鈥楽tem Cell Tourists鈥 Don鈥檛 Have To Travel Abroad, Study Says
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.
By Zhai Yun Tan -
FDA Eases Paperwork To Help Some Patients Get Experimental Drugs
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.
By Rachel Bluth -
Study Of Birth Defects, Folic Acid In Foods Finds More Questions Than Answers
But the authors caution against concluding that folic acid is ineffective.
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FDA Retreats From Recall Of Scope-Cleaning Machines Tied To Outbreaks
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.
By Chad Terhune -
FAQ: How The FDA鈥檚 New Tobacco Rule Affects Consumers
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.
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Shortages Of Essential Emergency Care Drugs Increase, Study Finds
The problems persist even after Congress in 2012 gave the FDA enhanced powers to respond when drug levels are low.
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Reforming Federal Oversight Of Medical Devices Won鈥檛 Be Easy
Despite dozens of infections from medical scopes, an agreement on how to fix the FDA鈥檚 flawed regulation of the device industry remains elusive.
By Chad Terhune -
You Can Buy Insulin Without A Prescription, But Should You?
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.
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Poll: Majority Of Americans Agree That The FDA Should Review Drug Ads Before They Air
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.
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Contraceptive Implant Under Microscope Amid Questions of Safety, Altered Trial Data
Essure has generated more than 5,000 complaints of serious side effects.