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Generic Sample Access Process For REMS-Protected Brands Now Includes Agency Timeline

 
• By Derrick Gingery

US FDA has 120 days to review generic sponsors’ requests for letters to help them obtain product samples, but will not send them to the reference product company.

writting a letter
FDA has issued 60 Covered Product Authorization letters • Source: Shutterstock

The US Food and Drug Administration process to issue letters helping generic sponsors obtain samples of products covered by a Risk Evaluation and Mitigation Strategy is being tweaked as interest in the program remains strong.

Since the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was enacted in December 2019, the agency has...

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Sun Strikes Further US Price-Fixing Settlement For $200m

 
• By Dave Wallace

The latest development in the long-running US generic price-fixing saga has seen Sun Pharma agree a $200m settlement in connection with an end purchaser action in Pennsylvania.

Just One Week To Go! Entry Deadline Looms For GGB Awards 2025

 
• By Dave Wallace

There is now just one week left to submit entries to the Global Generics & Biosimilars Awards 2025, with the entry deadline set for August 1.

UK Xtandi Patent Stands Strong As Accord, Sandoz, Teva Lose Appeal

 
• By Dean Rudge

The Court of Appeal in London has upheld a key UK patent shielding Astellas’ Xtandi, rejecting claims by a trio of generic drugmakers that it was obvious after finding that the generics firms’ expert analysis was tainted by hindsight.

‘Europe Has To Make Up Its Mind’ – Medicines For Europe’s Sieger On The Path Ahead

 
• By Dave Wallace

At an eventful time for the European generics and biosimilars industry, Medicines for Europe interim president and Polpharma CEO Markus Sieger talks about what the European healthcare sector needs and what the off-patent sector can deliver.

More from Products

‘Europe Has To Make Up Its Mind’ – Medicines For Europe’s Sieger On The Path Ahead

 
• By Dave Wallace

At an eventful time for the European generics and biosimilars industry, Medicines for Europe interim president and Polpharma CEO Markus Sieger talks about what the European healthcare sector needs and what the off-patent sector can deliver.

US Federal Circuit Clears Path for MSN to Market Entresto Generic

 
• By Dean Rudge

Novartis has failed to secure a court order to stop MSN from launching a generic Entresto, and has also seen an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.

Regulatory Recap: FDA Starts ‘Radical Transparency’ Era After Publishing Over 200 CRLs

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.