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Clinical Research Solutions
On Wednesday, September 28th, the FDA issued a final guidance document regarding the inclusion of the term “healthy” on the labels of food products. The guidance, entitled “Use of the Term ‘Healthy’...
Clinical Research Solutions
On Thursday, September 22nd, the FDA’s Center for Devices and Radiological Health (CDRH) released its regulatory science priorities for fiscal year 2017. CDRH & Regulatory Science According to CDRH,...
Clinical Research Solutions
Managing compliance for computerized lab systems includes the PC controlling your qualified instruments. This is an integral audit point that must be maintained to ensure compliance. Ah, but you’re...
Clinical Research Solutions
During the development phase of a new drug, great pains are taken to characterize the molecule and to run a myriad of laboratory and animal tests to determine the product attributes, toxicology...
Clinical Research Solutions
On Friday, September 9th, FDA announced the availability of a revised draft guidance, entitled “Health Document Submission Requirements for Tobacco Products.” The document was initially published in...
Clinical Research Solutions
On December 16, 2013, the FDA released a proposed rule regarding the safety and effectiveness of certain antibacterial soap products. If finalized, this ruling would require manufacturers of...
Clinical Research Solutions
With the spotlight these days on Data Integrity, it may be easy to lose sight of some fundamental Quality Systems. Core Quality Systems include Document Management, Investigation Management, and...
Clinical Research Solutions
On Wednesday, August 30th, the FDA announced the approval of Sandoz’s Erelzi™ (etanercept-szzs). Erelzi is biosimilar to Amgen’s Enbrel® (etanercept) and is indicated for the treatment of multiple...
Clinical Research Solutions
Additional information on FDA’s guidance document is available in our preceding FDA News article, entitled “FDA Extends Enforcement Deadline for Certain Provisions of the UDI Rule, Part One.” On...
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...