Articles by Larry Lian - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

  • Search
  • Suppliers
  • Careers

Enter a company or product name

Keyword Location
About Search
Articles by Larry Lian

Next Steps for the US Biosimilar Regulatory Scheme

With a regulatory pathway for follow-on biologics, industry is wondering what FDA will do next.
Mar 2, 2011

With a regulatory pathway for follow-on biologics, industry is wondering what FDA will do next.

The US Biosimilar Regulatory Scheme and Comparison with the European Experience: Where Do Where Go From Here?

The authors outline the key decision points FDA must consider in putting forth a US regulatory pathway for biosimilars.
Mar 2, 2011

The authors outline the key decision points FDA must consider in putting forth a US regulatory pathway for biosimilars.

ADVERTISEMENT

LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
FindPharma Custom Search
Click here