First Joint Clinical Assessments (JCAs): Key Lessons for EU HTA
The First JCAs Are Revealing More Than a New Process: Early Lessons and JCA Readiness
Regulatory Sciences
FDA Tightens the Reins on DTC Drug Ads: Big Picture Insights and Industry Implications
On Tuesday, September 9, 2025, the Department of Health and Human Services (HHS) and FDA both issued press releases and a fact sheet launching a crackdown on deceptive drug advertising. In the FDA's...
Quality & Compliance
How Mature Are Your Data Integrity Practices? New FDA and EU Regulatory Focus Areas
Data integrity has been in regulators' spotlight for decades, and the expectations for ensuring data integrity are evolving and increasing. This is partly because of the various Data Integrity...
Medical Information
The Shift Toward Globalization in Medical Information: How ProPharma is Helping Shape the Future in Japan
Over the past decade, the pharmaceutical industry has moved steadily toward the globalization of Medical Information (MI) services. Standard Operating Procedures (SOPs), harmonized processes, and...
Medical Information
Medical Information in the Netherlands: Safeguarding Compliance and Patient Confidence
Access to trustworthy pharmaceutical information is essential for patient safety and informed decision-making. In the Netherlands, medical information (MI) services are central to this goal,...
Regulatory Sciences
Tips for Preparing Successful FDA 510(k) Submissions
Securing FDA clearance through the 510(k) process is a critical milestone for many medical device manufacturers seeking market entry in the US. While the pathway is well-defined, many submissions...
Regulatory Sciences
FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2025
On September 25, 2025, FDA posted an additional 11 Untitled Letters from the cohort of letters issued on September 9, 2025, bringing the total number of compliance letters directed toward...
Quality & Compliance
How to Select the "Right" CMO Partner
There are many ways in which you can evaluate a Contract Manufacturing Organization (CMO) to identify the best fit for your company's needs. Every company knows timing is critical to success. But...
Regulatory Sciences
Decoding FDA’s Recent Advertising Enforcement Actions
The Agency’s Advertising Enforcement Letters Reveal Shifting Regulatory Priorities On Tuesday, September 16, 2025, FDA posted 40 Untitled Letters and 8 Warning Letters directed at prescription drug...
Regulatory Sciences
FDA Launches Crackdown on Deceptive Drug Advertising
On September 9, 2025, the US Department of Health and Human Services (HHS) and FDA unveiled a sweeping effort to clamp down on misleading direct-to-consumer (DTC) pharmaceutical advertising. The...
Quality & Compliance
Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Companies: A Tale of Two Paths
The Crossroads of Global Compliance For medical device and diagnostic companies operating in today’s global marketplace, success depends on more than just innovative products — it hinges on a...
Regulatory Sciences
FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?
On September 4, 2025, FDA announced a sweeping policy change: the real-time release of Complete Response Letters (CRLs); a continuation of FDA's July 10, 2025 publication of previously undisclosed...
Regulatory Sciences
Transparency Requirements and the Requirement for Document Redaction
In an era of increasing scrutiny and demand for transparency in clinical research, the European Union (EU) has taken significant strides to enhance public access to clinical trial data and ensure the...
Quality & Compliance
Why Project Management Is Essential, NOT a Luxury, for Today's Pharma Activities
When we meet with life sciences clients (especially small/mid-sized companies), Project Management (PM) is very rarely an area of importance. It is almost consistently an afterthought. Clients are...
Medical Information
Balancing Efficiency and Quality in High Volume Medical Information Contact Centers
In the pharmaceutical and medical information space, contact centers serve as a vital bridge between healthcare professionals, patients, and the companies that manufacture and distribute...
Regulatory Sciences
MAH Expertise Across Eastern Europe — and Beyond
Navigating pharmaceutical regulations across multiple countries isn't just about knowing the rules — it's about understanding the rhythm of each market, responding quickly to change, and having the...
