1. Pink Sheet
  2. >>Biosimilars & Generics
  3. >>Generics

FDA Seeks Input On Inactive Ingredients Database

US Agency Plans To Prioritize Maximum Daily Exposure Information

 
• By Dave Wallace

Industry input is being sought by the FDA on its inactive ingredient database, as the US agency considers how to prioritize the addition of maximum daily exposure limits as well as mulling the removal of specific dosage form information.

Grunge red inactive word with star icon round rubber seal stamp on white background
The FDA is seeking feedback on changes to its inactive ingredient database • Source: Thanee Hengpattanapong / Alamy Stock Vector

Input is being solicited by the US Food and Drug Administration on how best to prioritize the addition of maximum daily exposure information to its inactive ingredient database, as well as potentially modifying the IID structure to eliminate dosage form information.

Interested parties have until 21 June to submit comments to the FDA either electronically or in writing, with full details available at the Federal Register.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Generics

More from Biosimilars & Generics

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.