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Clinical Research Solutions
On Monday, August 8th, the FDA issued a final rule outlining its refuse to accept policy for tobacco product submissions that do not meet the minimum threshold for acceptability for FDA review....
Clinical Research Solutions
Late last month, FDA released a warning letter that had been sent to Xiamen Pharmaceutical Co., Ltd., outlining a number of “significant deviations from current good manufacturing practice (CGMP) for...
Clinical Research Solutions
On Friday, July 29th, the FDA issued a final guidance document entitled “General Wellness: Policy for Low Risk Devices,” which clarifies FDA’s Center for Devices and Radiological Health’s (CDRH’s)...
Clinical Research Solutions
According to section 503B(d)(4) of the Federal Food, Drug, and Cosmetic (FD&C) an outsourcing facility is “a facility at one geographic location or address that is engaged in the compounding of...
Clinical Research Solutions
FDA has announced its 2017 user fee rates related to the Generic Drug User Fee Program, which includes: Abbreviated new drug applications (ANDAs) Prior approval supplements (PASs) to an approved ANDA...
Clinical Research Solutions
On Friday, July 29th, FDA announced its 2017 Medical Device User Fee rates and payment procedures, which will take effect on October 1, 2016 and remain in place until September 30, 2017. These fees...
Clinical Research Solutions
The Biosimilar User Fee Act of 2012 (BsUFA) authorizes the FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development (BPD). These user...
Clinical Research Solutions
The Prescription Drug User Fee Amendments of 2012 (PDUFA V) allows FDA to collect user fees for the review of applications concerning human drug and biological products, the establishments where...
Clinical Research Solutions
On September 24, 2013, the FDA published the UDI Rule, which established a standardized identification system for medical devices used in the United States. Under this rule, the label and packages of...
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...