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Clinical Research Solutions
On September 23, FDA released a report regarding “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)”. This fulfills FDA’s PDUFA commitment to issue a report of findings...
Clinical Research Solutions
Many times in validation I am confronted with the problem of how to set acceptance criteria for critical process measurements. This is particularly true of in process measurements made during...
Clinical Research Solutions
I had lunch in a restaurant the other day. During my meal, I noticed that there weren't many other customers. I didn't give it much thought until I walked out and read the restaurant's hygiene grade...
Clinical Research Solutions
In June 2014, the FDA issued two draft social media guidance documents that may not clearly answer all of the questions that the drug and device industries have about how to use social media to...
Clinical Research Solutions
FDA recently updated its informed consent guidance in the form of an Information Sheet. The new document reflects the Agency’s current thinking on the informed consent process utilized in...
Clinical Research Solutions
Medical device manufacturers may need to re-think their approach to demonstrating substantial equivalence (SE) in the 510(k) notification process, due to the FDA’s recent finalization of the guidance...
Clinical Research Solutions
From time to time in this industry, you will hear someone bemoaning the fact that they have to do a cleaning validation. If this happens to be you, have no fear and remember the following five points...
Clinical Research Solutions
In a blog earlier this month, I mentioned that there are recent initiatives underfoot that FDA hopes will create FDA-industry partnerships, increase transparency, utilize data more effectively, and...
Clinical Research Solutions
Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes,...
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...