Clinical Research Solutions
Key Takeaways: New Draft Guidance on Cannabis and Clinical Research
On July 21st, 2020, the FDA released a draft guidance document for developers of cannabis and cannabis derived compounds, aptly titled “Cannabis and Cannabis Derived Compounds: Quality Considerations...
Quality & Compliance
7 “Aha Moments” in Data Integrity
If you are interested in data integrity, you likely have read many articles about the topic. This blog delivers 7 new insights to data integrity, looking at it from different angles. Seven ways to...
Clinical Research Solutions
4 Hidden Obstacles to Clinical Trial Success
It's no wonder scientists begin clinical trials with great excitement: combine promising discoveries with the best test sites, scientists, and as many qualified, willing patients as possible, and off...
Clinical Research Solutions
FDA Announces Plans to Resume Domestic Inspections with New Risk Assessment System
On Friday, July 11th, Stephen Hahn, MD, Commissioner of the FDA, issued a Coronavirus (COVID-19) Update, announcing the Agency's plans to resume "prioritized domestic inspections of FDA-regulated...
Regulatory Sciences
Improving Cost Efficiency, Speed, and Completeness of Generic Applications
An abbreviated new drug application (ANDA) is a “streamlined” marketing application that is submitted to the FDA for review containing information and data about a generic drug product. Once...
Clinical Research Solutions
The Key to a Stable Supply of Medicines
The COVID-19 pandemic revealed a structural weakness in many products' supply chains. In terms of supply of pharmaceutical products, supply shocks were not mitigated when intermediates or production...
Clinical Research Solutions
Lean Principles: A Life Sciences Overview
Today, with the FDA endorsing fewer new treatments, life sciences companies are pressured to develop better therapies while also struggling to control costs and retain their star employees. And while...
Clinical Research Solutions
A Guide to Understanding Long Term Follow-Up for Gene Therapy Clinical Trials
When conducting a clinical trial, there are many aspects sponsors need to be aware of with regards to clinical safety, product efficacy, and the ability to bring treatments through the multiple...
Clinical Research Solutions
How Should You Respond & React When Employees Become Infected with COVID-19?
On Friday, June 19th, the FDA issued a guidance document explaining what manufacturers of drugs and biological products should do, if and when, employees become infected with COVID-19. The...
Clinical Research Solutions
6 Tips for Evaluating Your CMO’s PAI Readiness
The submission of your drug application (NDA, ANDA, BLA, etc.) is an exciting accomplishment, and one of the first major milestones is a pre-approval inspection (PAI) of the manufacturing sites...
Clinical Research Solutions
How Opioid Analgesic Drugs are Approved by the FDA
The benefit-risk assessment is the cornerstone of how all drugs are approved. This assessment captures the scientific evidence, uncertainties, policy, and reasoning used by FDA officials to arrive at...
Clinical Research Solutions
Conducting a PAI Mock Inspection: How to Execute and Evaluate Your Findings
Did you miss our last blog on PAI Readiness? Catch up here to learn what a PAI is and how to prepare. Congratulations! You conducted a Mock Inspection in preparation for your upcoming Pre-Approval...
3 Factors to Consider in the Manufacturing Phase for Drug Device Combination Products
Combination products represent an important and growing category of therapeutic and diagnostic products. They come in several configurations and can be composed of any combination of a drug and a...
Clinical Research Solutions
Pediatric Labeling Best Practices
A large percentage of drugs are used off-label in pediatric patients. Unfortunately, when a patient uses a drug off-label, the drug is being used without FDA approval, which might result in...
Clinical Research Solutions
8 Common QMS Mistakes to Avoid
Previously in part two of this three-part blog series, “Mitigating Compliance Risk with Your Quality Management System,” we discussed how a robust and risk-based Quality Management System (QMS)...
Clinical Research Solutions
Mitigating Compliance Risk with Your Quality Management System
In the first blog of this three-part series, "Overlooking Your QMS Could Cost You," we discussed the cost of "good" versus "poor" quality, and the importance of investing in a "good" Quality...