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
Data collection and analysis is expensive and has the potential to compromise a company’s hard-won compliance position. It is therefore critical that technical leaders follow a systematic and proven...
Clinical Research Solutions
On March 20, 2018, the US Food and Drug Administration (FDA) released two new guidance documents to help companies comply with the December 20, 2016 final rule establishing postmarketing safety...
Clinical Research Solutions
MassBio is a non-profit organization that represents and provides support for the life sciences supercluster in Massachusetts. MassBio is committed to growing the industry, adding value to...
Clinical Research Solutions
On Friday, March 16th, the FDA published a notice in the Federal Register, stating that the effective date for the amendments related to intended use would be delayed indefinitely. In the notice, the...
Clinical Research Solutions
On Saturday, February 24, 2018, Health and Human Services (HHS) Secretary, Alex Azar announced that the FDA would be issuing guidance documents regarding expanded access to medication-assisted...
Quality & Compliance
Congratulations! You have a lead candidate formulation for your new drug. You might be thinking to yourself, “okay, now what?” We all know the science behind getting to this stage of having multiple...
Clinical Research Solutions
Throughout 2017, the FDA focused its attention on the regulation of generic drug products. In 2015, the Agency issued only two generic-related guidance documents. In 2016, there were seven. In 2017,...
Regulatory Sciences
Earning FDA approval for your drug program is a journey. A misstep at any point of that journey could jeopardize your chance at getting your drug approved. That’s why it’s so important to have a...
Clinical Research Solutions
At the beginning of each federal fiscal year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. I find that reviewing these metrics provides a valuable...
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...