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Clinical Research Solutions
Currently, there are no regulations specifically regarding investigational tobacco products. As such, at this time they are not exempt from requirements stated in the FD&C Act. Last week, FDA...
Clinical Research Solutions
FDA has released the fiscal year 2016 fee rate for using a rare pediatric disease priority review voucher. The new rate for 2016 will be $2,727,000, up from 2015’s rate of $2,562,000, and will take...
Clinical Research Solutions
FDA is investigating the use of tramadol, a narcotic-like pain reliever, in children aged 17 years and younger after learning of the “rare but serious” risk of slowed or difficult breathing....
Clinical Research Solutions
On June 11, 2010, FDA announced the availability of a guidance entitled “Bioequivalence Recommendations for Specific Products.” This document “explained the process that would be used to make...
Clinical Research Solutions
In the past, FDA has made a point that comments posted by individuals (in an individual capacity and not on behalf of an organization, corporation, or other entity) are not posted publicly. This is a...
Clinical Research Solutions
The FDA currently offers “orphan status” to drugs and biologics that are being developed as a treatment for a rare disease or disorder, which is defined as a condition affecting less than 200,000...
Clinical Research Solutions
FDA is implementing its authority to destroy a drug valued at $2,500 or less after being denied admission into the United States. The final rule was announced on the Federal Register on Tuesday,...
Clinical Research Solutions
Starting October 1, 2015, the FDA tropical disease priority review user fee rate is set to increase to $2,727,000, up nearly $200,000 from 2015’s rate of $2,562,000. Under the Prescription Drug User...
Clinical Research Solutions
Generating process data is expensive: Costs include materials, process time and the focus of highly-compensated subject matter experts. Unfortunately, many organizations don’t get their money’s worth...
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...