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...
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...
45 Years of 510(k) Submissions: FDA Celebrates with Improvements to the Process
In late 2018, FDA announced changes to modernize and increase the efficiency of its 510(k) clearance pathway, which is the most common medical device submission and allows for the allows for the...
Understanding Cybersecurity Threats to Medical Devices
The threat of cyber-attacks against medical devices is real. Medical devices capable of connecting, wirelessly, wired, or to portable media such as a USB drive, are more vulnerable to cybersecurity...
How to File Post-Approval Changes to an NDA or ANDA
On November 21, 1997, the Food & Drug Modernization Act (the Modernization Act) was enacted by Congress. Section 116 of the Modernization Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act...
United in Diversity: Six Tips for European Batch Release
Europe consists of 44 countries, and 21 supranational organizations and within the EU alone there are 24 official languages. So, how do you navigate the differences across Europe in the EU? And more...
Meet the Expert: Anchal Choudhuri
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...
Regulatory Sciences
Best Practices to Reduce Impurities in Generics
Recent recalls of dozens of lots of the front-line blood pressure and heart medications including valsartan, losartan, and irbesartan are placing the spotlight on impurities in generic drugs. After...
How to Prepare for the Three Type B Meetings with the FDA
The Food and Drug Administration (FDA) has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND meeting, the second is the End of Phase 2...