USA – FDA unveils FY 2025 user fee rates
The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2025 across its prescription drug, generic drug, biosimilar,...
USA – FDA official clarifies misconceptions around RWE in premarket submissions
Sponsors thinking of incorporating real-world evidence (RWE) into their submissions should consider RWE as just another form of clinical evidence, according to a recent...
USA – Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers
This guidance provides answers to commonly asked questions from applicants and other interested parties (collectively referred to as applicants throughout this guidance) regarding postapproval...
USA – FDA unveils rare disease innovation hub, plans public meeting this fall
The US Food and Drug Administration (US) announced the creation of a Rare Disease Innovation Hub to speed development of new treatments, integrate regulation...
USA – FDA guidance addresses developing treatments for pediatric IBD
The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to spur the development of new treatments for pediatric ulcerative colitis...
USA – FDA makes exception for antibody drug conjugates in mass balance studies final...
The US Food and Drug Administration (FDA) has finalized a guidance that lays out clinical pharmacology information that sponsors of investigational drugs conducting human...
USA – FDA issues final guidance user fees for combination products
The US Food and Drug Administration (FDA) on Tuesday finalized guidance for sponsors explaining how it assesses user fees for combination products and the...
USA – FDA releases draft guidance on use-related risk analysis for combo products
The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for...
USA – FDA drafts guidance on essential outputs for drug delivery devices
The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors of drug-device combination products in developing “essential drug delivery...
USA – Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological...
This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of...
