Consistent with goal of reducing and replacing animal testing
The Food and Drug Administration (FDA, Agency, or we) is announcing a level 2 revision of the final guidance entitled, “Pyrogen and Endotoxins Testing – Questions and Answers,” published in June 2012, and reissuing the final guidance as “Edition 2.” We are providing...General Considerations for the Use of NAMs in Drug Development
Docket Number: FDA-2025-D-6131 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “General Considerations for the Use...Heart-related death and death from gout medicine febuxostat (Uloric)
[ 11-15-2017 ] The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We...No significant increase in serious asthma outcomes with ICS/LABA
[12-20-2017 ] A U.S. Food and Drug Administration (FDA) review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious...All Drug Purchases Are
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