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.

Regulatory Sciences

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...

Regulatory Sciences

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...

Business Professionals Having Stressful Meeting

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....

European Union Flags Flying In Front Of Building in Brussels

Regulatory Sciences

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...

child-receiving-medical-care-rare-disease

Regulatory Sciences

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....

Regulatory Sciences

Leveraging Single-Arm Trials for Regulatory Approval: Insights from EMA's Reflection Paper

The pharmaceutical industry has shown a growing interest in single-arm trials due to their potential to expedite drug development. However, several challenges and concerns remain. The European...

Regulatory Sciences

Drug Development: The Key to Success from Concept to US Commercialization

Congratulations! You have a lead candidate formulation for your new drug. You might be thinking to yourself, “okay, now what?” We all know the science and effort to get to this stage is significant....

European Union flags outside of EU parliament

Regulatory Sciences

European Pharma Regulations: 2024 Review and 2025 Trends to Watch

Gaining a Competitive Edge: 2024's European Pharma Regulatory Review & Trends to Look for in 2025 and Beyond As the pharmaceutical landscape in Europe evolves rapidly, regulatory frameworks are...

1 2 3 4 5