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Regulatory Recap: FDA’s Rx Advertising Draft Needs A Stronger Voice, Say Commentators

FDA Finalizes Facility Readiness Guidance And Updates Drugs Without Competition List

 
• By Urtė Fultinavičiūtė

Generics Bulletin recaps the most recent regulatory news and updates from the FDA.

Hand holding an injection with FDA name in the background
• Source: Shutterstock

The comment period has ended for the US Food and Drug Administration’s recent draft guidance on promotional labeling and advertising for biologics and biosimilars.

The new guidance update, which was released in May, included promotional considerations unique to interchangeable biosimilars, which were absent in...

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More from Regulation

Bio-Thera Matches Alvotech With US Golimumab Filing Acceptance

 
• By Dean Rudge

Bio-Thera is one step closer to launching a biosimilar to Johnson & Johnson’s Simponi in the US, following FDA acceptance of its BAT2506 proposed golimumab candidate.

‘Our Position Has Naturally Shifted’ – How Standalone Sandoz Is Taking On Originator Abuses

 
• By Dave Wallace

As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

Making The UK A Leading Biosimilar Launch Destination – Realistic Or Optimistic?

 
• By Urtė Fultinavičiūtė

Experts discussed the UK government’s commitment to make the country a desirable destination for companies to launch their biosimilars at a recent conference hosted by Medicines UK.

More from Policy & Regulation

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

The Politics Of Divisionals: How European Patentees Are Still Gaming The System

 
• By Dave Wallace

At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.

Water Pressure: How European Industry Is Pushing Back On The UWWTD

 
• By Dave Wallace

Concern continues to build in the European generics industry over the threat posed by the EU’s Urban Wastewater Treatment Directive, which was one of the hottest topics of discussion at Medicines for Europe’s legal and annual conferences. And now, the association has intervened in a legal challenge.