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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...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• 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.

Shape Our Content: Take The Reader Survey

 
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We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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US FDA Upheaval Forces User Fee Talks To Begin Later Than Usual

 
• By Derrick Gingery

The fall start of PDUFA and GDUFA negotiations could impact the agreement review process and other parts of the schedule intended to ensure it reaches Congress on time.

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Project Orbis: 2025 Shaping Up To Be A Strong Year For Canadian Approvals

 
• By Eliza Slawther

Health Canada has approved four new drugs and 12 label variations so far this year via Project Orbis, a combined figure that already exceeds the annual approval figures for the two previous years. The agency explains the factors that impact annual approvals and highlights the pathway’s benefits.