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US FDA issues guidance on standardised numerical identifiers

 
• By Vibha Sharma

The US Food and Drug Administration has finalised guidance on standards for securing the drug supply chain by using a standardised numerical identifier on prescription drug packs1,2.

The US Food and Drug Administration has finalised guidance on standards for securing the drug supply chain by using a standardised numerical identifier on prescription drug packs1,2.

The guidance is the first in a series of several documents that the FDA will be developing on securing the...

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

 
• By Neena Brizmohun

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

 
• By Nielsen Hobbs

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’s ARIA Analysis Adds Earlier Scan To Biogen/Eisai Leqembi Label

 
• By Bridget Silverman

Six deaths early in treatment inspired a new safety requirement for Biogen/Eisai’s Leqembi to promote early identification of patients affected by the well-known risk of amyloid-related imaging abnormalities with edema (ARIA-E).

COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA’s Prasad

 
• By Sue Sutter

The CBER director rejected Pfizer’s assertions that pediatric dosing gaps, supply constraints and comparative mRNA content justify keeping the vaccine under emergency use authorization for younger children.

New US FDA AI Councils Will Focus On Internal, External Policy

 
• By Sarah Karlin-Smith

The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.