Creating a Roadmap for NDA Success: Key Steps and Considerations
The New Drug Application (NDA) submission process is a pivotal phase in the lifecycle of a drug, marking its transition from a promising compound in clinical trials to a marketable […]
Navigating the Complexities of FDA Advisory Committee Meetings
Preparing for an FDA Advisory Committee (ADCOM) meeting is both a significant and challenging milestone. This blog post aims to provide a strategic overview to guide your preparation efforts and […]
[FEATURED] EU Proposal To Have Guidance Transition Periods “Does Not Make Sense”
A proposed position paper on time periods for notified bodies to roll out guidance documents aims to introduce greater predictability. But has the EU notified body organization gone too far […]
