general regulatory

General Regulatory covers the frameworks and processes organizations use to comply with global laws and industry standards. Understanding regulatory expectations is essential for managing risk and maintaining product quality. This collection of articles discusses practical strategies for staying ahead of changing regulations.
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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....

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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...

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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...

Clinical Research Solutions

Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development

Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track The FDA has recently undergone a wave of layoffs that are beginning to...

Clinical Research Solutions

Navigating FDA Layoffs: OPDP Cuts and the Rising Stakes of Ad Compliance

The Importance of Compliance in Prescription Drug Advertising Amid Cuts to the Office of Prescription Drug Promotion The Office of Prescription Drug Promotion (OPDP), a key Office of the U.S. Food...

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Regulatory Sciences

Navigating a Shifting Regulatory Landscape: The Impact of FDA Layoffs on Medical Device Developers

On Thursday, March 27, 2025, HHS announced that they would be conducting a reduction in force impacting nearly 3,500 full time FDA employees – nearly 20% of the Agency’s entire workforce. This comes...

Regulatory Sciences

Scientific Data Works: Using Science to Navigate the Global Regulatory Maze

You’re developing an FDA – and/or EMA-regulated drug, biologic, or medical device. Throughout the drug development process, your goal is to get to the next regulatory milestone in the most...

Regulatory Sciences

FAQs: Model Informed Drug Development (MIDD) & Modeling and Simulation (M&S)

Question & Answer with Sander Vinks, PhD, PharmD, FCP, Regarding MIDD and M&S In the ever-evolving landscape of drug development, efficiency, precision, and regulatory success are paramount....

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Clinical Research Solutions

Navigating the New EU Health Technology Assessment Regulation (HTAR): Are You Ready?

The HTAR in the EU has come into force – what Health Technology Developers (HTDs) need to know Getting your health technology product to the market is complex and usually consists of several steps...

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Clinical Research Solutions

The End of the FDA’s Rare Pediatric Disease Priority Review Voucher Program

What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....

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