ANDA Review Times Will Not Come Down In Next Two Years, FDA Predicts

Estimates in President Obama’s budget request indicate the ANDA median review time will remain 42 months in FY 2015 and FY 2016, even though FDA also predicts a reduction in applications and an increase in approval actions.

The time it will take FDA to approve a generic drug application is not expected to budge through fiscal year 2016, an unsettling projection for the generic industry as it looks for improved review times in the user fee era.

FDA projects that the median time from ANDA receipt to approval will remain at 42 months, or 3

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

More from United States

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Smoldering Myeloma Endpoint Questions Carry J&J’s Darzalex Faspro To US FDA AdComm

 

The US FDA seeks advice on the clinical meaningfulness of the endpoints of J&J’s AQUILA trial in smoldering multiple myeloma, highlighting the pitfalls of being the first candidate for the precancerous condition.

US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
• By 

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

More from North America

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By 

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.

Will International Prices Influence Medicare Price Negotiation?

 
• By 

A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

US FDA Vaccine Framework Coming In Weeks, But Details Vague

 

New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.