ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
Clinical Research Solutions
In 2013, the FDA released a guidance entitled “Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements.” This guidance was finalized after...
Clinical Research Solutions
In May 2016, the FDA inspected Resonance Laboratories Pvt. Ltd.’s Bangalore manufacturing facility. During this inspection, the FDA investigator observed a number of significant deviations from...
Clinical Research Solutions
In the past two years, the FDA has approved two different types of intragastric balloon systems: Fluid-filled intragastric balloon systems, including the ReShape Integrated Dual Balloon System and...
Clinical Research Solutions
On Monday, February 6th, the FDA released the new process that will be used to collect and post curricula vitae (CVs) for advisory committee members. This will help FDA to post the appropriate CVs to...
Clinical Research Solutions
On Thursday, February 2nd, the FDA issued a safety announcement, warning consumers of rare but serious allergic reactions that have occurred with widely used skin antiseptic products containing...
Clinical Research Solutions
Phase-Appropriate Development and Application of Quality Systems in the Drug Development Process: The Parenteral Drug Association (PDA) recently published a revised version of Technical Report No....
Clinical Research Solutions
In October 2015, the FDA published a guidance document which outlines its recommendations regarding “the nonclinical evaluation of previously approved drug substances when a new formulation or a new...
Clinical Research Solutions
Last month, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and revised draft guidances that the Center plans to publish during the 2017...
Clinical Research Solutions
On August 8, 2016, the FDA issued a final rule outlining its refuse to accept policy for premarket tobacco product submissions failing to meet the minimum threshold of acceptability for FDA review....
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...