USA – FDA’s drug quality report card details enforcement trends, increased inspections in 2022
In its latest State of Pharmaceutical Quality report, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) cited an increase in...
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 – Generic drug lobby details extent of US shortages, offers possible solutions
The Association for Accessible Medicines (AAM) has issued a white paper urging the US Food and Drug Administration (FDA) and other policymakers to adopt...
USA – FDA pilot aims to boost transparency for oncology tests
The US Food and Drug Administration (FDA) is looking for up to nine drugmakers to join a pilot program intended to improve transparency for...
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Public comments submitted to the US Food and Drug Administration’s (FDA) draft guidance on how and when to inform the agency of certain drug...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...
