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...
Clinical Research Solutions
What to Expect From an FDA Inspection, Part 2
In this continuation from “Preparing for an FDA Inspection” I will discuss what I have witnessed as a typical outline of events for FDA inspections. Prior to setting foot at the facility, the FDA...
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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...
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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...
Medical Monitoring: Learning from the Past & Looking Ahead
Reflecting on the 1937 Elixir of Sulfanilamide incident we can clearly appreciate the importance of clinical trials and monitoring patient safety today. For those that may not know, Sulfanilamide was...
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Deep Dive: FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring
In January 2020, FDA published a guidance document entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient...
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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...
Enhancing CRO Capabilities with Independent Physician Services
The involvement of Medical Monitoring (MM) and Data Safety Monitoring Boards (DSMB) in trials has been somewhat unknown to individuals outside of clinical circles. That is, until media attention...
Clinical Research Solutions
FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring
Gene therapy holds the promise of curing severe genetic diseases at the genetic level rather than merely treating the symptoms as is accomplished using conventional small-molecule drug therapies. In...
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How to Understand and Avoid Common Phase 3 Failure Points
By the time the drug development process gets to Phase 3, it seems reasonable to assume that the chance of failure is relatively low. After all, the entire early-development process is at least...
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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...
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Understanding Responsible Person and Wholesaler Dealers Authorization
Wholesaling is a key factor for drug manufactures and Marketing Authorization Holders (MAH) to ensure supply of pharmaceutical products to their customers at pharmacies and hospitals. Wholesaling of...
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Project Management and a Successful Reduction in Investigations Backlog: The Beauty and the Beast
Many of us have been faced with this beast that needs taming: a regulatory agency has conducted an inspection of your facility. Their observation is that the backlog of investigations at your site is...
Understanding FDA Pre-ANDA Meetings
Brought into being by the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), the FDA’s pre-ANDA program is designed to accelerate access to generic versions of complex products. The...
Clinical Research Solutions
5 Steps to CMO Identification and Selection for Cell and Gene Therapies
After assuring clinical validity, finding and managing the right contract manufacturing organizations (CMOs)/contract development manufacturing organizations (CDMOs) is a Sponsor's major concern when...