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The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to spur the development of new treatments for pediatric ulcerative colitis...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USA – FDA releases draft guidance on use-related risk analysis for combo products
The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for...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The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors of drug-device combination products in developing “essential drug delivery...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...
USA – Drugmakers, compounders at odds over FDA’s difficult-to-compound rule
Drugmakers laud the US Food and Drug Administration’s (FDA) proposed rule on drugs that are difficult to compound by pharmacies and outsourcing facilities. Compounders,...
USA – FDA finalizes guidance on drug development for diabetic foot infections
The US Food and Drug Administration (FDA) finalized its advice to drugmakers developing treatments for diabetic foot infections without bone and joint involvement, focusing...
