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Clinical Research Solutions
On Wednesday, October 24th, FDA approved Xofluza (baloxavir marboxil), a single-dose oral flu medication. The product is indicated for the treatment of acute uncomplicated influenza (flu) in patients...
Clinical Research Solutions
On Friday, October 12th, FDA issued a guidance document entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The document aims to help...
Clinical Research Solutions
Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations (CROs). This ability to delegate through a Transfer of Regulatory...
Clinical Research Solutions
New rules, old facilities. How do these two meet? Is it a big black hole or is there light at the end of the tunnel? When you work in an older facility, you are probably acquainted with one-liners...
Regulatory Sciences
On Monday, October 1, FDA’s Center for Biologics Evaluation and Research (CBER) issued a document outlining the policies and procedures for scheduling and conducting INitial Targeted Engagement for...
Clinical Research Solutions
On Tuesday, September 25th, the FDA issued a guidance document entitled “ANDA Submissions – Content and Format.” The document, initially issued as a draft guidance in June 2014, provides sponsors...
Clinical Research Solutions
Details on the fundamental values outlined on FDA’s GRMP draft guidance are available in our preceding article, entitled “Good Review Management Principles & Practices, Part One: Fundamental Values"...
Clinical Research Solutions
On Tuesday, September 25th, the FDA published a draft guidance containing recommendations on good review management principles and practices (GRMPs) for new drug applications (NDAs), Biologics...
Clinical Research Solutions
On Tuesday, September 11th, FDA granted two de novo classification requests for mobile medical applications to be used with the Apple Watch. ECG App The first app, referred to as the ECG app,...
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...