A Frenzy Of Lobbying On 21st Century Cures
Three lobbyists for every member of Congress in a push to pass a bill that increases research funding and speeds up approvals.
FDA
441 - 459 of 459 Results
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Long-Stalled FDA Reform Sits On Senate’s Lame-Duck Calendar
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.
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FDA’s Drug Approval Team Copes With 700 Unfilled Jobs As Industry Lures Staff
The FDA’s drug-approval team is short more than 700 people and losing skilled staff members to the drug industry.
By Sydney Lupkin and Sarah Jane Tribble -
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.
By Chad Terhune -
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 — 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’s “revolving door” 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 ‘Stem Cell Tourists’ Don’t 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’s 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’t Be Easy
Despite dozens of infections from medical scopes, an agreement on how to fix the FDA’s 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.