1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

FDA Doubles Estimated Time Needed For DMF Completeness Assessment

 
• By Derrick Gingery

FDA now says Type II active ingredient drug master files should be submitted six months before the referencing ANDA to allow enough time for the completeness assessment. Delays could mean refuse-to-receive action for the ANDA.

FDA has strongly recommended drug master files arrive much earlier than initial estimates to avoid delaying the referencing ANDA, likely requiring more extensive planning for sponsors and further complicating the review process for both submissions.

The agency now is suggesting Type II active pharmaceutical ingredient DMFs should be submitted at least six months before the...

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 United States

Only One ANDA Was Submitted To The US FDA During The Shutdown; It Should Have Been None

 
• By Derrick Gingery

The FDA told the Pink Sheet an ANDA managed to be submitted during a period when no new ANDAs could be accepted.

Real Savings: Medicare-Negotiated Discounts On Cancer Drugs Range From 40%-60%

 
• By Cathy Kelly

Because they are not heavily rebated already, the discounts on four cancer treatments and a trio of other specialty drugs may benefit patients and the government more than others in the IPAY 2027 class.

Trump’s Semaglutide Most Favored Nation Price Will ‘Supersede’ Medicare MFP

 
• By Cathy Kelly

The Medicare negotiated price is slightly higher than the Most Favored Nation price recently announced by the Trump Administration.

AI Boosts Parkinson’s Disease Cell Therapy Development

 
• By Bridget Silverman

Aspen Neurosciences and BlueRock Therapeutics see hope for artificial intelligence to improve the quality of cell therapies to replace dopaminergic neurons in Parkinson's disease.

More from North America

US FDA Approves First Reformulated Rx Ranitidine, Five Years After Withdrawal

 
• By Malcolm Spicer

The FDA included storage and handling instructions common in labeling in its approval announcement, suggesting concerns remain about the potential for NDMA to form after products are distributed.

As US FDA Turns: Can Makary, Prasad And Pazdur Make It Work?

 
• By Michael McCaughan

The FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad, and Commissioner Martin Makary get along?

Obscure User Fee Provision Gives Generic Drug Sponsors More Time To Pay Fees Post-Shutdown

 
• By Derrick Gingery

ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.