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Regulatory Sciences
Recently, biosimilars have made a definite appearance on the FDA’s radar, an expected result after the first biosimilar product gained FDA approval in March and the FDA’s release of four final...
Clinical Research Solutions
On November 9, 2015, FDA launched the Orange Book Express application, which provides a list of the drug products approved by the FDA. What is the Orange Book? The Drug Price Competition and Patent...
Clinical Research Solutions
Issues for Sponsors with INDs and CMC concerns FDA recently released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy” as a supplemental guidance to “Guidance...
Clinical Research Solutions
In the space of a few years, Medical Information outsourcing has moved from being a last resort to become a core part of the service delivery strategy for most pharmaceutical companies. The speed of...
Clinical Research Solutions
I was recently asked to review a report summarizing the historic performance of a pharmaceutical process. The report consisted of the usual data tables and charts, but one thing caught my eye: data...
Quality & Compliance
The commissioning process is defined as "a quality-focused process for enhancing the delivery of a project. The process focuses upon verifying and documenting that all of the commissioned systems and...
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
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
In the previous installment of this blog, we discussed the importance of establishing a Master Validation Plan, and how to plan and assess your validation approach. Today’s segment will complete the...
Regulatory Sciences
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
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
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...
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...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
Clinical Research Solutions
In 2016, the FDA issued hundreds of 483 observations across the Drug and Device industries for failing to thoroughly review or investigate issues. This topic consistently hits the top five most...