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Clinical Research Solutions
President Obama recently signed the Improving Regulatory Transparency for New Medical Therapies Act into law. The law clarifies when controlled substances are officially approved by the FDA,...
Clinical Research Solutions
A common principle in Operational Qualification (OQ) studies is to challenge processes under worst case conditions. A "worst case" condition or set of conditions are generally those parameters...
Clinical Research Solutions
In the first quarter of 2016, the FDA will require all importers of FDA-regulated products to submit data necessary for international trade through a new electronic portal. What is ACE? The Automated...
Clinical Research Solutions
Believe it or not, project bullying in the workplace does exist. It is not a threat only at schools and on playgrounds. Project bullying can come for any source including the Project Manager, the...
Clinical Research Solutions
In collaboration with the National Health Information Sharing Analysis Center (NH-ISAC) and the Department of Health and Human Services, FDA is planning to hold a public workshop entitled “Moving...
Clinical Research Solutions
Update: Additional information on FDA's review of Essure is available in our FDA News article entitled "FDA Takes Steps to Ensure Patients are Informed of Safety Risks Associated with Essure" FDA...
Quality & Compliance
So what’s all the hub-bub about Digital Health? Is it really as big as they say? Is it just a fad? Is it all hype? Well, my answer is yes to all of the above. As with all major new technologies and...
Clinical Research Solutions
On September 25, 2015, FDA published a notice of proposed rulemaking (NPRM) regarding the regulation of products made or derived from tobacco. In the Federal Register announcement, "FDA requested...
Clinical Research Solutions
On November 17, 2015, FDA published a news release, announcing “the results of a yearlong sweep of dietary supplements to identify potentially unsafe or tainted supplements.” Background In...
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...