1. Pink Sheet
  2. >>Archive

Flexibility Or Formal Pathway? Avycaz Suggests FDA Doesn't Need Congress To Expedite Limited Use Antibiotics

 
• By Bridget Silverman

FDA steered Actavis' antibiotic Avycaz to approval for limited use based on limited data through the 505(b)(2) pathway, helped along by the agency's regulatory flexibility for medically important agents – making the Limited Population Antibiotic Development pathway under discussion on Capitol Hill look redundant.

The public health need for new antibiotics to stay ahead of inexorably developing antimicrobial resistance is unquestioned, but FDA's review of Actavis' Avycaz suggests the agency's regulatory creativity and flexibility can produce new drugs for patients with few options – without the formal fixes that are being proposed on Capitol Hill.

The Avycaz approval essentially followed the outlines of the Limited Population Antibiotic Development (LPAD) approach that has been featured in legislative proposals from the ADAPT and PATH Acts to the 21st

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 Archive

Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

More from Pink Sheet