USA – FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne...
Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of...
USA – FDA issues Q&A on importation of prescription drugs from Canada
The US Food and Drug Administration (FDA) has offered some clarity on the legal requirements for small entities to import prescription drugs from Canada.
In final...
USA – Top FDA official interested in ‘Project Orbis’ for cell and gene therapies
A top official from the US Food and Drug Administration (FDA) said he wants to see something similar to the agency’s Project Orbis program...
USA – HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules
The US Department of Health and Human Services (HHS) on Tuesday published a list of regulations its agencies will prioritize over the coming year....
USA – FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years...
USA – FDA updates draft guidance on division-level ANDA disputes
The US Food and Drug Administration (FDA) has published an updated draft guidance explaining how generic drug sponsors can ask for reconsideration of a...
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 impart lessons learned from quality management maturity pilots
The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or...
