Interchangeability

Random entry RSS

Posted in:
Regulatory

FDA Provides a Snapshot of the Biosimilar Development Programs
By C. Nichole Gifford February 8, 2017 Comments are off
Dr. Leah Christl, the FDA’s Associate Director for Therapeutic Biologics, Office of New Drugs Therapeutic Biologics and Biosimilars Team...

Read more

Tagged with: BSUFA II, FDA, Interchangeability, Regulatory

http://twitter.com/share?text="[TITLE]&url=[PERMALINK]
ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:
Regulatory

FDA Issues Draft Guidance on Demonstrating Interchangeability
By Seth Cockrum January 20, 2017 Comments are off
Introduction The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological...

Read more

Tagged with: BPCIA, FDA, Featured, Guidance, Interchangeability, Labeling, Regulatory

http://twitter.com/share?text="[TITLE]&url=[PERMALINK]
ShareEmail, Linked In, Twitter, Facebook, Google Plus

Back to Top