Drug Name Development: Regulatory Changes You Need to Know

2017 was a busy year for regulatory updates. Download our webinar to learn more about the changes we saw within the FDA, EMA and Health Canada.

Did you know every 6-month delay to launch can mean an average loss of $100 million[1]?

Depending on the market you’re looking to launch a product in, or what phase your drug sits in development, there are different regulatory factors and milestones you need to be aware of. When it comes to naming your asset, you need a partner to guide you through these milestones to develop the best regulatory submission strategy.

In 2017, the FDA introduced new guidance for naming biosimilars and biologics, and the EMA made changes to their name review schedule that will impact submission deadlines and planning. This year, the industry began to understand the impact Health Canada’s 2015 naming guidance is having on drug name approvals.

But how do these changes affect your trade name development and regulatory name submission strategies?

Download our webinar to learn more about these regulatory changes from the industry leader in drug naming.

 

Share This


Previous

Next
Hero Image
Your Brand’s Guide to Corporate Change
Your Brand’s Guide to Corporate Change
FIND OUT MORE
Hero Image
Naming biosimilars – regulatory guidance you need to know
Naming biosimilars – regulatory guidance you need to know
FIND OUT MORE