Author Archives: Emily Alexander

Before starting Phase I 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 pharmacologyRead more

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 actionableRead more

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