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Clinical Research Solutions
On Monday, February 29th, FDA celebrated the ninth annual Rare Disease Day by announcing its new grant program, which will award $2 million in research grants to fund natural history studies for rare...
Clinical Research Solutions
FDA to Require Tobacco Retailers to Implement Effective Training Programs for Employees On Friday, February 26th, the FDA announced plans to issue a guidance requiring tobacco retailers to establish...
Clinical Research Solutions
As FDA’s Track-and-Trace Requirements go Into Effect, the Agency Issues a New Guidance for Trading Partners Engaged in Transactions with First Responders On February 29, 2016, the FDA published a...
Clinical Research Solutions
On Tuesday, February 23, the US Senate confirmed Robert Califf, MD to serve as the next FDA Commissioner. The position, held by Margaret Hamburg, MD for six years until she resigned in March 2015,...
Clinical Research Solutions
On Thursday, February 25th, FDA announced plans to hold a public workshop to discuss the evidentiary standards necessary to support biomarker qualification. The workshop, entitled “Developing an...
Clinical Research Solutions
Imagine for a moment that this is your current situation… You receive a frantic call from the receptionist at your facility, an Investigator from the Food and Drug Administration (FDA) has just...
Clinical Research Solutions
Additional information on FDA’s recommendations for interoperable medical devices is available in our blog post entitled “A Closer Look at FDA’s Draft Guidance Regarding Premarket Submissions for...
Clinical Research Solutions
Starting with the issuance of a 483, the stepwise FDA enforcement process can be illustrated as follows: Given the seriousness of a Seizure and Injunction scenario, not to mention potential jail time...
Clinical Research Solutions
On February 18, 2016, the FDA issued a final order which will require the submission of premarket approval (PMA) applications for metal-on-metal (MoM) total hip replacement devices, which are hip...
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...