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Clinical Research Solutions
The Regulatory Guidance embodied by ICHQ8 through (soon to be written) ICHQ12 tells us in no uncertain terms that we must protect the patient across the product lifecycle by assuring quality based on...
Clinical Research Solutions
On February 16, 2016, FDA published a guidance document that provided blood establishments with recommendations to reduce the risk of contaminating the US blood supply with the Zika virus. On Friday,...
Clinical Research Solutions
On Thursday, August 11th, FDA released a revised draft guidance, entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” The revised document was issued “to improve...
Clinical Research Solutions
As Phase I clinical trials mark the first time that an investigational new drug is administered to humans, these studies are subject to appropriate current Good Manufacturing Practices (cGMP) in...
Clinical Research Solutions
On Wednesday, August 17th, the FDA issued a final rule regarding when a substance is generally recognized as safe. FDA states that the final rule is intended to amend and clarify the criteria in its...
Clinical Research Solutions
On Monday, August 15th, FDA issued a notice requesting nominations for a nonvoting member to serve on the Tobacco Products Scientific Advisory Committee to represent the interests of tobacco growers....
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
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
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...
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
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...
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...
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...