The use and implementation of new approach methodologies (NAMs) and digital technologies such as artificial intelligence (AI) may help improve the predictability and interpretation of central nervous system (CNS) toxicity through non-clinical safety assessments, according to a recent paper proposing a new safety framework for predicting neurological risk in CNS drug development.
The US Food and Drug Administration (FDA) issued final guidance on 13 August regarding the types and timelines for formal meetings that sponsors can request during the development of new drugs and biological products.
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web.
Industry and other stakeholders want the US Food and Drug Administration (FDA) to provide more clarity and ensure flexibility in a revised guidance on how drug and medical device makers should communicate with payors and other stakeholders about their products.
The US Food and Drug Administration (FDA) on Thursday released its proposed commitment letter for the Prescription Drug User Fee Act (PDUFA VIII) program, outlining its performance goals and program enhancements for the program for FY 2028-2032.
A trade group has asked European authorities to give notified bodies access to the Eudamed database to empower them to deliver the risk-based oversight proposed in the pending medtech regulatory reforms.
RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the inside scoop on the topics everyone will be talking about and their tips for making the most of your week. Next up: Pujitha Gourabathini, quality assurance manager at BD.
Following months of negotiations with industry, the US Food and Drug Administration (FDA) has published its proposed commitment letter for the Generic Drug User Fee Amendments (GDUFA IV) program.
