Quality & Compliance
Navigating the Impact of New Tariffs: Strategies for Success Amidst Recent Trade Policy Changes
The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy. Significant changes have been announced causing many global organizations to investigate...
Medical Information
Medical Information in the UK: Ensuring Compliance, Patient Safety, and Trust
In the highly regulated world of pharmaceuticals, medical information (MI) services play a critical role in ensuring that healthcare professionals, patients, and the public have access to accurate...
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....
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...
Medical Information
German Pharmaceutical Compliance: The Critical Role of Medical Information Teams
When a pharmaceutical company completes clinical trials and prepares to launch a medical product, the focus often shifts to regulatory approvals, market access, and commercialization. However, one...
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....
Pharmacovigilance
Signal Detection and Management - The Pursuit of Safer Products
Signal detection for products in development Why signal detection in clinical development? Early safety signal detection enables: Early identification of safety risks Informed decision making Meets...
Regulatory Sciences
Challenges in Clinical Development of Products for Rare Disease
Rare diseases are defined in the Orphan Drug Act as diseases or conditions that affect less than 200,000 people in the United States. There are over 7,000 rare diseases affecting more than 30 million...
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....
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...
Medical Information
Excelling in the JAPAC Medical Information Landscape: Key Considerations and Insights
As a rapidly expanding market, the Japan and Asia-Pacific (JAPAC) region presents a unique and complex landscape for those who are looking to establish a medical information (MI) function. Having a...
Regulatory Sciences
Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding
On November 27,2024, FDA released a draft guidance intended “to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the...
Regulatory Sciences
Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe
Background Developing medical devices (MDs), including in vitro diagnostic medical devices (IVDs), requires careful and result-oriented planning throughout the development process. One critical...
Regulatory Sciences
FDA Releases Final ICH M13A Guidance Document
On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”. This guideline provides...