Careful planning is important for all early drug development programs, but it is particularly critical in rare diseases where study populations are limited and precedents for drug development are lacking. Pre-IND meetings with the FDA give sponsors the opportunity to discuss their unique development challenges and determine where regulatory flexibility can be justified. While the...
There are many pitfalls that come with preparing an Investigational New Drug (IND) application for FDA submission, but with the right plan – and the right partner – there are also plenty of ways to avoid them. The most important strategy? It all comes down to one thing: Always remember to keep your audience –...
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...
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...
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...