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Clinical Research Solutions
On August 28, 2008, FDA announced a draft guidance entitled “Integrated Summary of Effectiveness.” On Wednesday of this week, more than seven years later, the Agency released the final version of the...
Clinical Research Solutions
FDA is launching a pilot project to integrate Risk Evaluation and Mitigation Strategies (REMS) into Structured Product Label (SPL) format. This will facilitate the sharing of documents and ease the...
Clinical Research Solutions
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
On September 28, 2015, Sen. David Vitter (R-LA) sent a letter to FDA’s Acting Commissioner, Stephen Ostroff, MD, in which he stated various concerns regarding an extensive backlog of Abbreviated New...
Clinical Research Solutions
In the case between Mylan Pharmaceuticals and Warner Chilcott, in which Mylan accused Warner Chilcott of violating antitrust laws by participating in “product hopping”, the FTC has filed an amicus...
Clinical Research Solutions
The Trans-Pacific Partnership trade deal was agreed to by the United States and 11 other Pacific Rim nations on Monday, making it the largest regional trade agreement in history. The agreement, which...
Clinical Research Solutions
Sandoz, the generic pharmaceuticals division of Novartis, is the global leader in biosimilar products. On March 6, 2015, FDA approved Zarxio, a biosimilar version of Amgen’s Neupogen (filgrastim)...
Clinical Research Solutions
This week FDA finalized its draft guidance on Controlled Correspondence Related to Generic Drug Development. Although all submitted comments were considered, FDA’s revised the draft to “provide...
Clinical Research Solutions
The Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed on July 9, 2012, introduced and described a new designation – Breakthrough Therapy Designation. According to FDA,...
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...