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

ANDAs Get More Time – Or Maybe Less – To Correct Minor Deficiencies

 
• By Derrick Gingery

FDA final guidance says sponsors will have seven calendar days to fix small application flaws instead of five business days; industry had wanted 10 business days.

ANDA sponsors may or may not gain more time to fix minor deficiencies under finalized guidance even though FDA allowed more days to compile and submit responses.

FDA changed the time to respond to less than 10 minor deficiencies without losing the original ANDA receipt date to...

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

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.