Mutual mistrust: FDA staff wary as Høeg becomes top drug regulator
WASHINGTON — In 2008, Tracy Beth Høeg, then a resident physician and ultramarathon runner, expressed dismay at vice presidential candidate ...
Tag: FDA
FDA panel urges easier access to testosterone therapy for men
Exactly a month after it announced the removal of black box warning labels on estrogen therapy products used in menopause, ...
FDA approves US-manufactured antibiotic under new priority review program
Tony Webster / Wikimedia Commons The Food and Drug Administration (FDA) yesterday approved a US-manufactured version of the oral antibiotic ...
FDA claims Covid vaccine caused kids’ deaths. Experts are skeptical
The Food and Drug Administration’s top vaccine regulator asserted in an email to staff sent Friday that the Covid-19 vaccine ...
FDA reviewers didn’t get to vote on first priority voucher drug
WASHINGTON — The Food and Drug Administration has promised companies that earn a Commissioner’s National Priority Voucher a one- to two-month ...
Bayer Lung Cancer Drug Lands Speedy FDA Nod to Stay Competitive With a Boehringer Ingelheim Med
A Bayer drug designed to target tumors driven by a rare genetic mutation now has accelerated FDA approval, providing another ...
FDA lifts major warnings on hormone replacement therapy
The U.S. Food and Drug Administration (FDA) is eliminating the prominent "black box" warnings on many hormone replacement therapy (HRT) ...
FDA Will Remove Warnings for HRT Products Used for Menopause
The Food and Drug Administration will remove black box warnings from hormone replacement therapy (HRT) products, which are often used ...
FDA Adds 6 More Meds to Pilot Program for Speedy Review of Drugs in the National Interest
Two obesity drugs are among the six new medications that could get faster FDA review under a new pilot program ...
New FDA priority review vouchers go to Lilly, Novo, Vertex
WASHINGTON — The Food and Drug Administration on Thursday announced the second batch of companies being granted a “Commissioner’s National Priority ...
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