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Clinical Research Solutions
In the previous installment of this blog, we discussed the importance of establishing a Master Validation Plan, and how to plan and assess your validation approach. Today’s segment will complete the...
Clinical Research Solutions
In 2013, FDA introduced a new set of regulations that would establish a unique device identification system for medical devices. They also announced the dates for implementation, which would be done...
Clinical Research Solutions
Last month FDA published a guidance (titled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements”) announcing that they...
Clinical Research Solutions
After the FDA passed the Orphan Drug Act in 1983, the number of orphan drugs (drugs indicated for the treatment of rare diseases that affect 200,000 people or less in the United States) submitted to...
Clinical Research Solutions
After being accused of “misbranding” their product, Amarin Pharma, a pharmaceutical company that manufacturers Vascepa, a cardiovascular health drug, recently challenged the FDA after promoting the...
Clinical Research Solutions
On July 19, 2015, Kim Kardashian posted a “selfie” to her Instagram and Twitter accounts. You may be thinking “She does that all the time… Why would that matter to the FDA?” The selfie in question...
Clinical Research Solutions
On August 4, 2015, the FDA announced the availability of a guidance outlining the Agency’s updated Refuse to Accept policy for 510(k)s, that is scheduled to take effect starting October 1, 2015. This...
Clinical Research Solutions
Do you find yourself in one of the following situations? + Your equipment has broken down due to frequent usage or wear and thus requires repair. You realize that once repaired, any equipment will...
Clinical Research Solutions
As many of us know, searching for an FDA guidance document from the past can be a rather daunting task. That is until recently… Guidances are one of the most requested and searched for items on 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...