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Clinical Research Solutions
Critical Components of Quality Management Systems: In 1962, Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP), which must be compliant...
Clinical Research Solutions
As we’re sure already you know, last week North Americans experienced a total solar eclipse. Leading up to the big event, thousands of articles and blog posts were written about the historical event...
Clinical Research Solutions
On Friday, July 28, 2017, the FDA released a new, comprehensive plan concerning the regulation of tobacco and nicotine. This multi-year regulatory plan is part of the Agency’s attempt to protect...
Clinical Research Solutions
What Should Be on Your Clinical Trial Investigator Site Audit Checklist?: You live and operate in a regulated industry. Obviously, it’s crucial that you stay in compliance during your clinical...
Clinical Research Solutions
On Tuesday, July 11th, FDA released its draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for the electronic submission of this...
Clinical Research Solutions
On Friday, July 7th, the FDA approved Endari (L-glutamine oral powder) to reduce the complications associated with sickle cell disease in patients age five years and older. What is Sickle Cell...
Clinical Research Solutions
In 2016, the FDA issued hundreds of 483 observations across the Drug and Device industries for failing to thoroughly review or investigate issues. This topic consistently hits the top five most...
Clinical Research Solutions
The FDA’s focus on data integrity in recent years has proven that it remains an industry issue. The focus has resulted in significantly increased issuance rates of 483 observations, warning letters,...
Clinical Research Solutions
On June 15, 2017, Hospira Inc. issued a voluntary recall of a number of its products after finding a microbial growth during a routine simulation of the manufacturing process, which represents the...
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...