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Clinical Research Solutions
FDA to Study How Superimposed Text in Direct-to-Consumer Drug Ads Impacts Consumer Comprehension Over the past few weeks, the FDA announced plans to launch public surveys and conduct studies relating...
Clinical Research Solutions
FDA is planning to do some major housekeeping when it comes to direct-to-consumer (DTC) drug advertisements. Based on a number of recent announcements, the Agency is planning to study various aspects...
Clinical Research Solutions
On February 25, 2016, the International Organization for Standardization (ISO) published its updated ISO 13485 guidance. The guidance, which was originally published in 2003, is the global standard...
Clinical Research Solutions
As we’ve now moved on from another cold winter month, I was captivated recently thinking about Quality Assurance and our collective responsibilities. All kinds of things come to mind; Deviations,...
Clinical Research Solutions
As a part of its ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), the FDA has announced its plans to review the proposed Nonclinical Study Data Reviewer’s Guide (SDRG)...
Clinical Research Solutions
Additional details on the opioid epidemic are available in our FDA News article, entitled "Califf Pledges to Review FDA’s Opioid Policies to Address US Opioid Epidemic" In early February, Dr. Robert...
Clinical Research Solutions
Additional information on FDA's review of Essure is available in our previous FDA News article entitled "Coming Soon: FDA Safety Review of Essure" On Monday, February 29th, FDA announced that it will...
Clinical Research Solutions
Late last month, FDA announced plans to launch a public survey to ask patients about their experiences with direct-to-consumer (DTC) drug advertisements. Background In 2002, the FDA surveyed patients...
Clinical Research Solutions
Data integrity is a current hot topic, but not a new one, within the life sciences industries and associated product supply chains. This article will not delve into why there have been so many recent...
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...