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Clinical Research Solutions
On October 21, 2015, Senators Joe Donnelly (D – IN) and Cory Gardner (R – CO) announced two new bills – the Rare Device Innovation Act and the FDA Regulatory Efficiency Act – which the pair will be...
Clinical Research Solutions
On March 3, 2014, FDA announced a proposed rule that would amend the regulations regarding the labeling of conventional foods and dietary supplements. In this announcement, the Agency sought feedback...
Clinical Research Solutions
On October 21, 2015, FDA released a draft guidance entitled “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose,...
Clinical Research Solutions
Last week former NBA star Lamar Odom was hospitalized when he was found unconscious in a Las Vegas What is Reload? Reload, also referred to as “herbal Viagra” or a “natural” product, is a...
Clinical Research Solutions
On Wednesday, October 13, 2015, FDA released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy.” The document provides information and recommendations regarding...
Clinical Research Solutions
I was recently asked to review a report summarizing the historic performance of a pharmaceutical process. The report consisted of the usual data tables and charts, but one thing caught my eye: data...
Clinical Research Solutions
The Prescription Drug User Fee Act (PDUFA) gives FDA the authority to collect fees from companies that produce certain human drug and biological products. Background PDUFA was enacted in order to...
Clinical Research Solutions
FDA’s previous guidance establishing a biosimilar naming convention could be the leading cause of the Agency’s delay in releasing the highly anticipated guidance on interchangeability and labelling...
Clinical Research Solutions
FDA wants to know how much of the information presented in television advertisements consumers understandGem, and how much more information they could handle. In an effort to answer these questions,...
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...