cber

Clinical Research Solutions

What You Need to Know About CBER Pre-IND Meetings

The FDA provides several opportunities to hold meetings with Sponsors to gain clarification and agreement on the development of medicinal products. At the preliminary stages of development, one such...

Clinical Research Solutions

FDA Sets A Deadline For Electronic Submission Of Drug Applications

In a final guidance published in the Federal Register on May 5, FDA laid out the rules and specifications for providing regulatory submissions in electronic format. Perhaps more important than the...