Expert analysis on the changing landscape of drug development and global compliance.
Clinical holds can delay drug development by months or years. We analyze the most common triggers for FDA holds in the current regulatory climate and how to avoid them.
The FDA has recently updated its framework for gene therapy products, emphasizing long-term safety monitoring and manufacturing consistency. Here is what biotech sponsors need to know to prevent clinical holds.
Beyond tax credits, Orphan Drug Designation offers strategic advantages including seven years of market exclusivity. Here is how to construct a winning ODD application.
How Mevoq helped a mid-sized pharma client secure FDA Accelerated Approval using a surrogate endpoint, shaving 3 years off their development timeline.
Approval is just the beginning. Maintain your license and avoid warning letters with this comprehensive checklist for CMC changes and Annual Reports.
The transition to eCTD v4.0 is approaching. Learn about the new bidirectional communication features and how to upgrade your submission publishing systems.