1. Pink Sheet
  2. >>Product Reviews

Novel Approvals Were Fewer But Faster At US FDA In 2016

 
• By Bridget Silverman

While the total of 22 new molecular entities and therapeutic biologics approved in 2016 was lower than in recent years, the average time to approval was shorter than ever – thanks to historically high proportions of priority review agents and first-cycle approvals in the class.

2016-2017 Biopharma in Perspective

The average time from submission to approval for novel agents approved by FDA's Center for Drug Evaluation and Research in 2016 was only 10 months, the shortest average in the contemporary era.

But while speedy, the CDER class of 2016 is also unusually small. The final count of 22 novel approvals is the lowest annual total for the center since 2010, and is less than half of the almost two-decade high of 45 reached in 2015

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 Approvals

More from Product Reviews

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 
• By Sue Sutter and Bridget Silverman

The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.