Generic Liability: Supreme Court Appears Divided On Whether ANDA Sponsors Must Seek Label Change When New Risks Emerge

In oral arguments in Pliva v. Mensing, justices suggest generic companies have an obligation to ask FDA to revise labeling; Chief Justice John Roberts Jr. says that could lead to boilerplate letters to FDA.

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

 

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.

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Brazil Pilots Digital Drug Pack Inserts

 

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

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Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.

Beijing City Releases AI Action Plan Including Drug Regulation

 
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Amid the wait for an action plan to apply AI tools to drug regulation at the national level in China, capital city Beijing has released its own vision of scenarios for the technology in the healthcare sector.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.