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

In Switching Generic 'Reviews' To 'Assessments' Is US FDA Changing More Than Just A Word?

 
• By Derrick Gingery

MaPP revision may be just a better description of ANDA evaluations – or indicative of a broad culture change, experts tell the Pink Sheet.

RulesRegulationsBooks_1200x675

The US FDA's decision to change ANDA "reviews" to "assessments" may represent a sea change in its approach to generic drug reviews. Or it could simply be a more accurate description of the increasingly complicated application evaluation system. Opinions of the significance of the new wording, which was recently rolled out in an internal FDA policy manual, appear to stretch the gamut.

Attorney Kurt Karst, director at Hyman, Phelps and McNamara, said in an interview with the Pink Sheet that it is only a terminology change. He said the agency now is emphasizing how ANDA evaluations always have been assessments

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

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.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.