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Digital Transformation in Life Sciences: The Importance of Data Strategy
What is Digital Transformation?
While there are many different definitions of digital transformation in life sciences, the core concepts they all have in common are digital technology and creating new, or modifying existing, ways of working. The underlying business driver is that digital...
FDA Works to Reduce Medical Errors, Part One: Background & Overview of FDA’s Proprietary Naming Guidance
In September 2007, the Prescription Drug User Fee Act (PDUFA IV) was reauthorized and expanded, broadening and strengthening FDA’s drug safety program. As part of PDUFA’s reauthorization, the Agency...
FDA Works to Reduce Medication Errors, Part One: Background & Overview of FDA’s Proprietary Naming Guidance
In September 2007, the Prescription Drug User Fee Act (PDUFA IV) was reauthorized and expanded, broadening and strengthening FDA’s drug safety program. As part of PDUFA’s reauthorization, the Agency...
On Friday, April 8th, the FDA announced revisions to the labeling of metformin, the prescription drug for type 2 diabetes. Metformin is an oral medication that helps control blood sugar levels in...
On Tuesday, April 5th, FDA announced the approval of Inflectra™ (infliximab-dyyb), a biosimilar version of Janssen Biotech's Remicade® (infliximab), for a number of indications. Inflectra is...
Report: FDA’s Drug Review & Approval Times Reduced Drastically Since 2009
According to an infographic report from the California Life Sciences Association (CLSA), FDA approval times have decreased by nearly 50% since 2009. The infographic, entitled “Tracking FDA Drug...
FDA Releases Anxiously Awaited Biosimilar Labeling Guidance, Part 2: Label Content
More on FDA’s draft guidance in our preceding FDA News article, entitled “FDA Releases Anxiously Awaited Biosimilar Labeling Guidance, Part 1: An Overview of FDA’s Recommendations.” Late last month...
FDA Releases Anxiously Awaited Biosimilar Labeling Guidance, Part 1: An Overview of FDA’s Recommendations
On Thursday, March 31st, FDA released a highly anticipated draft guidance addressing the requirements for biosimilar labels. The draft guidance, entitled “Labeling for Biosimilar Products,” is...
At the time of this writing, there were 59 registered 503b outsourcing facilities posted on the FDA’s website. All firms that had been inspected were issued FDA inspectional observations in the form...
On Monday, April 4th, FDA announced a publication entitled “Modifications to the List of Recognized Standards, Recognition List Number: 041,” which contains modifications to the list of standards FDA...
Understanding Statistical Intervals: Part 2 - Prediction Intervals
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...
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...
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...
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...
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...
Formal FDA Meetings for Sponsors or Applications of PDUFA Products
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...