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Quality & Compliance
Advanced Therapy Medicinal Products (ATMPs), or Cell and Gene Therapies (CGT), have the incredible potential to cure devastating illnesses, such as cancer, on a more personalized level. But, due to...
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...
Regulatory Sciences
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...
Regulatory Sciences
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...
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...
In July 2018, FDA issued a draft guidance document entitled "Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient...
Quality & Compliance
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...
Clinical Research Solutions
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...
Quality & Compliance
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...
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...
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...
Quality & Compliance
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...
Quality & Compliance
The ultimate goal of the U.S. Food and Drug Administration is to protect the public welfare and protect consumers from unsafe products. Regulatory investigators are responsible for enforcing...
Regulatory Sciences
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...
Quality & Compliance
The implementation of a robust Quality Management System (QMS) is a key success factor for clinical development with the goal of reaching marketing authorization. As important as your QMS is during...
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...