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Clinical Research Solutions
In a recent interview with The Telegraph, Tim Cook, CEO of Apple®, discussed a variety of topics, including the Apple Watch and the production of a “government-licensed health product,” to name just...
Clinical Research Solutions
Last week FDA released its highly anticipated internal social media policy. The document explains the roles, responsibilities, and requirements governing the personal use of social media by FDA...
Clinical Research Solutions
As we discussed in previous FDA News articles (here and here), the Agency is in the midst of developing “novel ways to optimize its regulation of Next Generation Sequencing (NGS) tests.” The Agency’s...
Clinical Research Solutions
As we discussed in a previous FDA News article, the Agency is in the midst of developing “novel ways to optimize its regulation of Next Generation Sequencing (NGS) tests.” The Agency’s ultimate goal...
Clinical Research Solutions
Background On April 29, 2009, FDA announced a final rule that required labels of certain over-the-counter (OTC) pain relievers and fever reducers to include warnings about potential safety risks,...
Clinical Research Solutions
On September 15, 2015, President Obama announced Robert M. Califf, MD, MACC, as his nominee for Commissioner of the US Food & Drug Administration (FDA). Dr. Califf is a world renowned cardiologist...
Clinical Research Solutions
FDA recently teamed up with the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) to develop and publish a draft guidance entitled, “Minutes of Institutional...
Clinical Research Solutions
In 2002, the Medical Device User Fee and Modernization Act (MDUFMA) was passed, which introduced the first user fees for medical devices. MDUFMA established a system which would require medical...
Clinical Research Solutions
On November 9, 2015, FDA launched the Orange Book Express application, which provides a list of the drug products approved by the FDA. What is the Orange Book? The Drug Price Competition and Patent...
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...