Meet the Expert: Marshall Scicchitano
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
FDA’s Breakthrough Therapy Designation vs PRIority MEdicines (PRIME) Application in Europe
What are Breakthrough Therapy Designation and PRIority MEdicines (PRIME) Applications? The advancement of modern medicine, and the accessibility of researched and regulated medication, has greatly...
Regulatory Strategy for Clinical Trials in the European Union
Setting up a clinical trial in the European Union (EU) has historically been an expensive and time-consuming business. With 27 individual member states each requiring its own review and approval, it...
Is it Time to Sharpen Your Target Product Profile (TPP)?
Is it Time to Sharpen Your Target Product Profile (TPP)? We’ve heard it countless times: "Fail early and live to fight another day." "Preserve capital, human resources, and energy for a project with...
Regulatory Sciences
Understanding Bioequivalence and Product-Specific Guidances
The FDA regularly issues new and revised product-specific guidances to facilitate the availability of generic drugs and assist the generic pharmaceutical industry with identifying the most...
Meet the Expert: Daniel Solorio
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
European Expedited Regulatory Programs Explained
Do you really know how to accelerate the approval of your innovative product in Europe? The FDA's incentives for promising new medicines are widely known. Accelerated approval, priority review, fast...
Four Benefits of Requesting an FDA Pre-IND Meeting
Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...
Regulatory Sciences
Critical Issues in Drug Development: Don't Get Derailed in Developmental Efforts
Pharmaceutical companies spend massive amounts of money on drug development. Regardless of a firm’s size, the investment is substantial; the smallest error can have catastrophic consequences,...
How to Present Scientific Data That Generates Regulatory Approvals
Today’s patients benefit from having access to the safest, most advanced pharmaceutical systems around the world. This is because of the work done by the various regulatory bodies who govern the...
Meet the Expert: Hanna Edling
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Have an FDA Submission on Your 2021 To-Do List?
At the start of every year, we all have these grand plans of everything we plan to accomplish. It is a fresh start to really get stuff done and we have a full 12 months to do it all. However,...
Meet the Expert: Marla Scarola
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Understanding The Medical Device Single Audit Program
The Medical Device Single Audit Program (MDSAP), initiated by the International Medical Device Regulators Forum (IMDRF), created a global approach to auditing and monitoring the manufacturing of...
The Human Factor - Preparing Your Device for Usability Testing
When it comes to usability studies, the focus should be on effectively preparing the medical device for use in humans. Whether a Sponsor is conducting formative testing or validation testing, the...
Pedaling While Fixing a Flat: Conducting a Good FDA Meeting Under Bad Circumstances
Before using a significant risk medical device in a clinical study, Sponsors must first obtain FDA approval. Frequently, the request for an investigational device exemption (IDE) is disapproved, and...