FDA Announces OTC Monograph Drug User Fees for Fiscal Year 2022
Monday, March 14, 2022 Today, the U.S. Food and Drug Administration announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022 in a Federal Register Notice...
6 Ways Data Science Can Improve Your Life Sciences Operations
The proper use of data science and predictive analytics can improve any online business, in or out of the medical field, but plays a particularly unique role in the life sciences. Science seeks truth...
What is Software Quality Assurance (SQA) and Do You Need it For Your Business?
If your only method of quality assurance is software testing, you’re wasting valuable time and resources. Software Quality Assurance (SQA) is integrated into your software development life cycle to...
The Quality of Your Medical Writing Matters (And Here’s Why)
Medical writers need to meet a few critical criteria before they publish their work. First and foremost, people want to see accuracy and explicit knowledge of the field when they’re seeking out...
How to Sustain Compliance with EU MDR (2017/745) After the Deadline
The Medical Devices industry breathed a sigh of relief for the new European Medical Device Regulation (EU MDR), but the May 2021 deadline is now right around the corner. The transition from the...
The Evolution of Medical Writing
Medical writers must not only have solid writing skills, but knowledge in the context and terminology of medical topics. At times, they may even need to analyze the logic of a passage. Examples of...
5 Ways the Medical Industry is Using Data Science
In the era of technological disruption, data science is a disruptor for the books. Today’s data scientists develop processes, algorithms, and systems to mine structured and unstructured data with the...
Do You Need a Resource Management Team?
In the latest PMI report Pulse of the Profession 2020 (2020), 11.4% of surveyed organizations attribute investment waste to poor project performance. What defines project performance and ultimately...
Enterprise Resource Planning (ERP) Systems in the Medical Industry
Drug and medical device development and manufacturing is a complex process that involves multiple supply chains, various monitoring systems, and countless players from R&D to market. Due to the...
