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Drug-Drug Interactions: Future FDA Guidance Will Focus On Specific Modalities; Patient Website To Come

 
• By Kate Rawson

US FDA took ‘broadest’ approach possible with initial guidance on drug-drug interactions; additional documents will dive into issues specific to different therapeutic areas. But PK/PD modeling and AI alternatives will have to wait.

drug umbrella
US FDA’s ‘umbrella’ DDI guidances will be supplemented with modality-specific documents. • Source: Shutterstock

The US FDA will supplement its two “umbrella” final guidances on drug-drug interactions with additional guidance documents that address clinical pharmacology recommendations for specific therapeutic areas and “emerging” modalities, Office of Clinical Pharmacology Guidance & Policy Team Associate Director Rajanikanth Madabushi said during a 12-13 December “deep dive” webinar on FDA’s work on drug-drug interactions.

Since publishing two final guidance documents in January 2020 on general clinical and in vitro approaches to evaluating potential drug-drug interactions, FDA has included DDI recommendations in three...

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UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

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