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Time To Spare? US FDA “Opioid-Sparing” Guidance May Take Longer Than Expected

 
• By Michael McCaughan

In August, it sounded like FDA was almost ready to issue guidance on “opioid-sparing” claims for acute pain treatments. After a November advisory committee meeting, that doesn’t seem to be the case.

Car mechanic replacing timing belt at camshaft of modern engine - Image
This timing belt needs to be replaced. Could it speed up FDA's opioid guidance development?

When the US FDA announced an Nov. 15 advisory committee meeting to discuss “the assessment of opioid analgesic sparing outcomes in clinical trials of acute pain,” it sounded like a forum to unveil a rough draft of a promised guidance on that topic.

The agency had been indicating for almost a year that a guidance was likely. FDA disclosed that it was developing guidance during a February advisory committee review of one potential “opioid-sparing” therapy – Pacira Pharmaceuticals Inc.’s liposomal bupivacaine formulation Exparel

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US FDA Vaccine Framework Coming In Weeks, But Details Vague

 
• By Sarah Karlin-Smith

New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.

HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 
• By Derrick Gingery

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.

US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 
• By Derrick Gingery

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
• By Laura Helbling

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.

More from Pathways & Standards

US FDA Vaccine Framework Coming In Weeks, But Details Vague

 
• By Sarah Karlin-Smith

New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 
• By Derrick Gingery

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.