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Quality & Compliance
Artificial Intelligence (AI) is moving quickly from pilot projects into routine pharmacovigilance (PV) operations. The 2025 CIOMS Working Group XIV report on AI in pharmacovigilance provides a...
Regulatory Sciences
Why Early Planning Matters for Regulatory Operations While it's only been a handful of years since eCTD Version 3.2.2 became the standard submission format for all major components of US regulatory...
Quality & Compliance
In today's complex life sciences ecosystems, pharmaceutical and biologics companies face unprecedented demands to deliver safe, effective therapies while navigating a global regulatory environment...
Regulatory Sciences
2025 was a year of significant regulatory disruption. One that will have lasting implications for how pharmaceutical companies approach advertising and promotion in 2026. From an unprecedented surge...
Medical Information
In the highly regulated industry environment, medical information (MI) services are far more than a support function, providing information to patients, caregivers, and Healthcare Professionals;...
Quality & Compliance
The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommended that the current version of Annex 11 on Computerised Systems be revised to reflect changes in regulatory and...
Pharmacovigilance
Living near the ocean growing up, I have been warned countless times that by the time you realize you are in a riptide, you may already need to be rescued. You'll know things aren't going quite...
Quality & Compliance
Artificial Intelligence (AI) and Machine Learning (ML) technologies are transforming the life sciences landscape, driving innovation across drug discovery, clinical research, manufacturing, and...
Regulatory Sciences
As digital marketing evolves, prescription drug promotion is expanding into spaces traditionally dominated by consumer brands. Pharmaceutical companies are increasingly collaborating with...
Regulatory Sciences
For many US and APAC pharmaceutical companies, reacquiring the European rights to a successful, out-licensed product is a smart strategic move — an opportunity to capture greater margins, regain...
Regulatory Sciences
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
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
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
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
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...
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...
What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...
The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...
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....