Regulatory Sciences
FDA's "Radical Transparency" Shift: What Regulatory Pros Need to Know
A New Era of FDA Disclosure On Thursday, July 10, 2025, FDA published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications...
Regulatory Sciences
Leveraging Online FDA Information to Accelerate ANDA Timelines
In the race to generic drug approval, timing is everything. Delays in Abbreviated New Drug Application (ANDA) submissions or setbacks during FDA review can mean missed market opportunities,...
Regulatory Sciences
Maximizing the Value of FDA Pre-IND Meetings for Successful 505(b)(2) NDA Submissions
For drug developers leveraging the 505(b)(2) pathway, the FDA Pre-Investigational New Drug (Pre-IND) meeting is a strategic opportunity that can shape the trajectory of an entire development program....
Regulatory Sciences
FDA's Commissioner’s National Priority Voucher (CNPV) Pilot Program Overview
An inside look at FDA's new Commissioner's National Priority Voucher (CNPV) pilot program—what it is, why it matters, and how regulatory and development teams can leverage it to accelerate...
Regulatory Sciences
Navigating FDA's Q-Submission Process: A Strategic Advantage for Medical Device Developers
In the highly regulated medical device industry, navigating FDA's submission process can be daunting, especially for start-ups. However, FDA's Q-Submission (Q-Sub) program offers a valuable...
Quality & Compliance
15 Days of Panic Revisited: You Received an FDA Form or 483 Form Warning Letter, Now What?
Remember the last time you were pulled over by law enforcement? Maybe it was for a broken taillight or driving a few miles over the speed limit. Even if you believed you hadn't done anything wrong,...
Regulatory Sciences
Expanding into Europe? Accelerate Your European Marketing Authorization
For non-European pharmaceutical companies, expanding into the European market is both an exciting opportunity and a formidable challenge. While the potential for growth is significant, so too are the...
Regulatory Sciences
Navigating the German Pharmaceutical Landscape: Part Two
Market Access, Pricing, and Additional Compliance Considerations In part one, we explored the German pharmaceutical market and regulatory compliance requirements. Now, in part two, we will focus on...
Regulatory Sciences
Navigating the German Pharmaceutical Landscape: Part One
Regulatory Considerations and Market Entry Germany is home to one of the most advanced healthcare systems in the world, making it an attractive but complex market for pharmaceutical companies. A...
Regulatory Sciences
The Key to Understanding Pricing and Reimbursement in the Nordics
It is easy to think that when you finally receive market approval for your drug, you have reached the finish line. However, what many do not realize is that there is still a final hurdle that can be...