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Clinical Research Solutions
On Thursday, April 27th, the “Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was reintroduced by members of the Senate & House Judiciary Committees. The CREATES Act is a...
Clinical Research Solutions
The landscape of clinical trials is evolving. The changes that are happening are due to the increased number of FDA-regulated trials, as well as a rise in the complexity of clinical protocols. As...
Clinical Research Solutions
On Thursday, April 27th, the FDA announced the approval of Brineura™ (cerliponase alfa). Brineura, manufactured by BioMarin International Ltd., is an infusion indicated for the treatment of...
Clinical Research Solutions
On Tuesday, April 25th, the FDA released warning letters that were recently issued to 14 US-based companies. These warning letters were issued with regards to the illegal sale of products that claim...
Clinical Research Solutions
On Friday, April 21st, Reneflexis® (SB2, infliximab – abda) was approved by the FDA. Reneflexis is manufactured by Samsung Bioeipis, and is a biosimilar product to Janssen’s Remicade® (infliximab)....
Clinical Research Solutions
At the beginning of each year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. Image Source: FDA I find that reviewing these metrics provides a...
Clinical Research Solutions
On Thursday, April 20th, the FDA formally ordered both Texas and Arizona to refuse and either destroy or export all execution drugs within 90 days. Background Texas was the first state to begin...
Clinical Research Solutions
On Thursday, April 20th, the FDA issued a statement announcing a number of changes that are being made to the labeling requirements for two opioids – codeine and tramadol. The Agency’s statement...
Clinical Research Solutions
On Friday, April 14th, a draft bill was released, aimed at reauthorizing the user fee programs for branded and generic drugs, medical devices, and biosimilar products. Committees from the House of...
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...