FDA Releases Latest Product-Specific Guidances

Of 36 PSGs, 22 Are New And 14 Newly-Revised

The latest tranche of product-specific guidances for generic development has been published by the US FDA.

Number 36 House Sign
The FDA has published 36 new or newly-revised product-specific guidances • Source: Shutterstock

The US Food and Drug Administration has published its latest batch of product-specific guidances for generic drug development, with the 36 newly-released documents comprising 22 new guidances and 14 newly-revised PSGs.

“To further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Generics

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

 
• By 

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.

ViiV Extends Voluntary License For Long-Acting Cabotegravir As HIV Treatment

 

The Medicines Patent Pool’s extended voluntary license to produce long-acting cabotegravir to treat HIV is a win for patients living in LMICs, as the WHO updated its guidance to recommend it as an alternative treatment option.

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

 
• By 

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.

MSN’s Entresto Generic Temporarily Blocked As Key US Patent Expires

 
• By 

The Federal Circuit has temporarily blocked MSN from launching a generic version of Entresto, granting Novartis short-term relief while it reviews the company’s emergency Rule 8 motion for a longer injunction.

More from Products

MSN’s Entresto Generic Temporarily Blocked As Key US Patent Expires

 
• By 

The Federal Circuit has temporarily blocked MSN from launching a generic version of Entresto, granting Novartis short-term relief while it reviews the company’s emergency Rule 8 motion for a longer injunction.

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

 

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.

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

 
• By 

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.