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Clinical Research Solutions
The 21st Century Cures Act, (Passed December 13, 2016), represents three years of cooperation between Congress, the FDA, and industry to modernize the current legal framework within which the FDA...
Clinical Research Solutions
The recent passage of the 21st Century Cures Act (passed December 13, 2016) marks a significant milestone for medical device and drug development. I recently attended a meeting held by the Food and...
Clinical Research Solutions
On September 7, 2005, FDA announced the availability of a draft guidance, entitled "How to Comply with the Pediatric Research Equity Act," providing sponsors with a number of recommendations...
Clinical Research Solutions
In May 2014, the FDA published a guidance document entitled “Expedited Programs for Serious Conditions – Drugs and Biologics.” The intention of the document was to provide drug makers with an...
Clinical Research Solutions
On November 3rd and 4th, I had the opportunity to meet with Pharmaceutical industry experts at the PDA Outsourcing / CMO conference in Washington, DC. It was a fantastic event with representatives...
Clinical Research Solutions
In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative, which explained FDA’s intent of integrating quality systems and risk management approaches, and had a goal...
Quality & Compliance
For a number of years, discrepancy and failure investigations within the pharmaceutical industry have been populating the Top 3 of a Food and Drug Administration (FDA) Observation list....
Clinical Research Solutions
The Food and Drug Administration (FDA) released a draft guidance on the Special Protocol Assessment (SPA) in May 2016, updating the original SPA guidance issued in 2002. SPAs are meant to give...
Clinical Research Solutions
In October 2009, the FDA issued a guidance document regarding its expectations for investigators during the conduct of clinical investigations.The guidance, entitled Investigator...
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...
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...
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...
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...
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...
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...