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FDA Promises More Off-label Guidances As Part Of First Amendment Harmonization

 
• By Brenda Sandburg

Agency grants two citizen petitions from a coalition of pharma companies requesting greater clarity from FDA, but whether the forthcoming guidances will satisfy industry remains an open question.

Conceding to the requests of a coalition of pharmaceutical companies, FDA said it will issue additional guidances this year to clarify its policies on the communication of off-label uses of marketed drugs and devices.

Specifically, the agency will be releasing a draft guidance that addresses requests involving healthcare economic information, as well as guidances...

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More from United States

Liver Injury REMS Delays US FDA Approval Of Agios’s Pyrukynd In Thalassemia

 
• By Mandy Jackson

Approval in alpha- and beta-thalassemia by the Sept. 7 action date seemed assured, but an FDA review of a proposed REMS for potential liver injury pushed the decision to Dec. 7.

Sticker Shock? Cost Of Orphan Drug Medicare Negotiation Relief May Complicate Future Fixes

 
• By Cathy Kelly

Heavy lobbying produced relief for orphan drugs in President Trump's budget reconciliation law and the cost of the changes to Medicare now is becoming clearer.

Complete Response Letters: Will Industry Fight US FDA’s Disclosure Plans?

 
• By Sue Sutter

The FDA's release of CRLs for unapproved products could bring a court challenge, but for now, sponsors should expect all past and future letters will be made public, experts said.

Pink Sheet Podcast: US FDA Drops Offit From Adcom, Releases Unapproved Product CRLs

 
• By Derrick Gingery, Bridget Silverman, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the recent departure of a noted vaccine expert and many others from FDA advisory committee rosters, as well as the details and potential impact of the FDA’s release of dozens of complete response letters for unapproved products.

More from North America

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 
• By Bridget Silverman

The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.

Kennedy Maintains mRNA Negativity Even When Couched As Trump Success

 
• By Sarah Karlin-Smith

The Health and Human Services Secretary's Sept. 4 appearance at the Senate Finance Committee also revealed more Republicans are souring on his vaccine policies, although most still support him.

US FDA’s New ‘Plausible Mechanism Of Action’ Pathway Limited To Bespoke Therapies

 
• By Sue Sutter

Center for Biologics Evaluation and Research Director Vinay Prasad and Commissioner Martin Makary will introduce the new pathway soon in a New England Journal of Medicine article.