USA – FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes
Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve...
USA – FDA details policy on facility reclassification requests under GDUFA III
The US Food and Drug Administration (FDA) recently issued a manual of policies and procedures (MAPP) on the procedures it will follow in following...
USA – Guidance details updated FDA GDUFA fees, structure and appeals process
The US Food and Drug Administration (FDA) published a final guidance last week that updates the agency’s user fee structure and other aspects of...
USA – FDA officials say high priority will be given to applications with endpoints...
Under the US Food and Drug Administration (FDA) rare disease endpoint advancement pilot program (RDEA), preference will be given to applications with well-developed efficacy...
USA – Manufacturers seek clarity on FDA’s drug shortage notification guidance
Public comments submitted to the US Food and Drug Administration’s (FDA) draft guidance on how and when to inform the agency of certain drug...
USA – FDA seeks feedback on ICH E6(R3) GCP guideline
The US Food and Drug Administration (FDA) has started its public consultation for the International Council for Harmonisation (ICH) guideline on good clinical practice...
USA – FDA officials: ‘Significant work’ still needed for rare disease drug development
While much progress has been made in approving treatments for rare diseases, more work is needed in this area, asserted Kerry Jo Lee, MD,...
USA – FDA officials tout steady growth in biosimilar program, enhancements under FDORA
US Food and Drug Administration (FDA) officials touted “steady growth” in the total number of biosimilar products since the program’s inception, with 40 approvals...
USA – Accelerated approval trials: Commenters seek details on single-arm considerations
The US Food and Drug Administration (FDA) aimed to address some of the criticisms of its accelerated approval program with new draft guidance that...
USA – FDA finalizes drug-drug interaction guidance for therapeutic proteins
The US Food and Drug Administration (FDA) on Friday issued a final guidance to assist sponsors in determining whether to conduct drug-drug interaction studies...
