Tag: Investigational New Drug Applications

Consulting

5 Tips to Avoid an IND Clinical Hold: Regulatory Guidance and Insights

A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies. In this blog, we discuss common reasons for clinical holds and provide useful tips for both avoiding and addressing them. Brief background...

Clinical Research: Phase 1 - Phase 4

Investigational New Drug (IND) Applications: 4 Common Mistakes

Before starting Phase 1 trials, an Investigational New Drug (IND) application must be approved by the FDA. This critical early step in clinical trial development grants an exemption to laws prohibiting the transportation of drugs across state lines prior to market approval. The three major required areas of information in an IND include: Animal pharmacology...

Clinical Research: Phase 1 - Phase 4

Investigational New Drug Applications: 5 Solutions to Common Problems

There are many pitfalls that come with preparing an Investigational New Drug application for FDA submission. Luckily, there are also plenty of ways to avoid them. But the most important strategy? It all comes down to one thing: Always remember to keep your audience (the FDA reviewers) in mind as you write. These five actionable...