1. Generics Bulletin
  2. >>Policy & Regulation
  3. >>Regulation

Generic Labeling Rule Defies Predictions, Remains In FDA's Long-Term Pipeline

 
• By Michael Cipriano

Policy that would allow generic sponsors to change product labels has been delayed yet again, not spiked completely, even with Commissioner Gottlieb's known opposition to the rule.

Machinery cogwheels, industry concept

When Scott Gottlieb was tapped by President Trump to be commissioner of the US FDA, it was almost a forgone conclusion that the agency would scrap a proposed rule that would allow abbreviated new drug application (ANDA) sponsors to change their product labels without getting prior approval.

But at least for now, it appears FDA is simply pushing the proposed rule to the backburner.

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
Start Free Trial

Already a subscriber?

More from Regulation

Sandoz Scores Regional First With EU Launch Of Autoinjectable Stelara Rival

 
• By Adam Zamecnik

Doubling down on the launch of its Stelara biosimilar Pyzchiva in Europe last year, Sandoz has just released an autoinjectable version of the drug, with the aim to offer a more convenient option for ustekinumab patients.

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 
• By Anju Ghangurde

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.

Trump-Trimmed FDA Finally Releases A Batch Of PSGs – Back To Business As Usual?

 
• By Urtė Fultinavičiūtė

After half a year of silence, the US FDA has published 48 product-specific guidances for generic development. With critical staff laid off, will the health agency stick to its updated PSG publishing schedule?

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

More from Policy & Regulation

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

Fresenius Adds To Denosumab Competitors In Europe

 
• By Dave Wallace

At a busy meeting of the CHMP, the EMA issued positive opinions for Fresenius Kabi’s denosumab rivals to Prolia and Xgeva, another denosumab biosimilar from Sandoz, a Tecfidera hybrid from Neuraxpharm and a Descovy generic from Viatris. Meanwhile, Ascend has withdrawn a teriparatide filing.

Regulatory Recap: ICH To Determine The Future Of Biosimilar Comparative Efficacy Studies

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.