USA – FDA draft guidance paves way for more real-world, point-of-care clinical trials
The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance that’s intended to pave the way for using data from research...
USA – FDA’s final guidance on DCTs adds clarity on HCP task log, inspection...
The US Food and Drug Administration’s (FDA) final guidance on decentralized clinical trials (DCTs) addresses some key issues from the draft guidance raised by...
USA – Studies find uneven uptake of biosimilars as availability increases
As biosimilars become increasingly available, they are creating a competitive market with originator products, but uptake of biosimilars among patients is varied and depends...
USA – FDA drafts guidance on multiregional clinical trials in oncology
In a new draft guidance, the US Food and Drug Administration (FDA) provided recommendations for multiregional clinical trials (MRCTs) in oncology, encouraging sponsors to...
USA – FDA updates guidance on classifying ANDA amendments for GDUFA III
The US Food and Drug Administration (FDA) on Thursday issued updated guidance on the classification of amendments to abbreviated new drug applications (ANDAs) or...
USA – FDA revises final guidance on nitrosamine impurities
The US Food and Drug Administration (FDA) on Wednesday issued a revised final guidance to assist manufacturers in detecting and controlling nitrosamine impurities in...
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...
