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...

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The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to spur the development of new treatments for pediatric ulcerative colitis...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USA – FDA releases draft guidance on use-related risk analysis for combo products

The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for...

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