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Clinical Research Solutions
The Regulatory Guidance embodied by ICHQ8 through (soon to be written) ICHQ12 tells us in no uncertain terms that we must protect the patient across the product lifecycle by assuring quality based on...
Clinical Research Solutions
On February 16, 2016, FDA published a guidance document that provided blood establishments with recommendations to reduce the risk of contaminating the US blood supply with the Zika virus. On Friday,...
Clinical Research Solutions
On Wednesday, August 24th FDA released a final guidance document, entitled “Abbreviated New Drug Application Submissions – Refuse to Receive for Lack of Justification of Impurity Limits,” which...
Clinical Research Solutions
Last week the FDA released an astonishing 23 warning letters along with an import alert to a number of companies located across the globe. According to a recent article from Law360, the letters were...
Clinical Research Solutions
On Thursday, August 11th, FDA released a revised draft guidance, entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” The revised document was issued “to improve...
Clinical Research Solutions
As Phase I clinical trials mark the first time that an investigational new drug is administered to humans, these studies are subject to appropriate current Good Manufacturing Practices (cGMP) in...
Clinical Research Solutions
During product development some sponsors struggle to determine how their product will be regulated by the FDA. Will it be considered a drug, medical device, biologic, or combination product? Based on...
Clinical Research Solutions
On Wednesday, August 17th, the FDA issued a final rule regarding when a substance is generally recognized as safe. FDA states that the final rule is intended to amend and clarify the criteria in its...
Clinical Research Solutions
On August 9, 2016, the FDA issued five public notifications advising consumers not to purchase or use a number of products, including: Citrus’ Fit Adelgazantes R-II Boss-Rhino Gold X-tra Strength...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
Clinical Research Solutions
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...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
Clinical Research Solutions
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
Regulatory Sciences
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...