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US FDA explains info needed for formal product classification requests

 
• By Vibha Sharma

The US Food and Drug Administration has issued revised guidance explaining the type of information that companies should submit when seeking a formal determination of the regulatory identity of their product as a drug, device, biological or combination product1,2. The company's request for designation (RFD) results in the FDA assigning the product's pre-market review responsibility based on the product's "primary mode of action".

The US Food and Drug Administration has issued revised guidance explaining the type of information that companies should submit when seeking a formal determination of the regulatory identity of their product as a drug, device, biological or combination product1,2. The company's request for designation (RFD) results in the FDA assigning the product's pre-market review responsibility based on the product's "primary mode of action".

The latest RFD guidance supersedes the version that has been in place since August 2005. The revised guidance has been issued by the FDA's Office of Combination Products and is...

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• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

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Brazil Pilots Digital Drug Pack Inserts

 
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Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

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ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.