Regulatory Sciences
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...
Regulatory Sciences
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...
Clinical Research Solutions
7 Benefits of Working with a Biostatistician
Biostatisticians have become increasingly important as many data-driven public health projects and clinical trials have expanded. So, what exactly does a biostatistician do? These individuals are...
Clinical Research Solutions
How to Select the "Right" CMO Partner
There are many ways in which you can evaluate a Contract Manufacturing Organization (CMO) to identify the best fit for your company’s needs. Every company knows, timing is critical to success. But...
A Roadmap for Clinical Trials: QP Certification of IMP
Please note that updates to regulations may have been implemented since the publication of this article. The 20th century was the century of many scientific discoveries in the field of medicine....
Clinical Research Solutions
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...
Regulatory Sciences
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...
Clinical Research Solutions
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,...
6 Benefits of Custom PMO Design
A Project Management Office ("PMO") can be incredibly advantageous to large companies with many ongoing projects across various job sites. A PMO streamlines project management processes to make a...
Life Science Outsourcing: Not sure you’re ready to turn over the keys?
It's no secret. To be successful in the life sciences industry you must accomplish a lot – achieve and maintain profitable growth, deliver safe and effective products to patients quickly, manage...
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...
FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring – Focus on Documenting Test Results & Post-Licensure Considerations
In January 2020, FDA issued a final guidance document on the topic of "Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture...
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...