Latest California Healthline Stories
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.
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.
FDA Wants To Tighten The Screws On Stem Cell Clinics
As more and more clinics offer controversial treatments, especially in California, the agency is seeking to clarify its regulatory standards.
Congressman Decries Olympus’ Failure To Warn U.S. Hospitals About Tainted Scopes
U.S. Rep. Ted Lieu (D-Torrance) renews his call for tightened laws that would force manufacturers to notify the U.S. Food and Drug Administration when they issue safety warnings in other countries related to the design and cleaning of their devices.
Olympus Told U.S. Executives No Broad Scope Warning Needed Despite Superbug Outbreaks
Internal emails show that after the Tokyo-based device maker alerted customers in Europe in 2013, it told its U.S. operation not to widely warn U.S. doctors and hospitals. Since then, at least 35 patients have died after being sickened in outbreaks.
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.
But the authors caution against concluding that folic acid is ineffective.
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.
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.
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.