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Clinical Research Solutions
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...
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...
Last week, I introduced a two-part series on transformation leadership. We defined transformational leadership, explored the concept, and discussed the benefits of adopting this approach. Well, now...
Selecting the right contract research organization (CRO) is one of the most important decisions you, as a sponsor, must make. That’s because CROs can improve efficiency and increase productivity,...
Quality & Compliance
A couple of years ago, an organization asked me to present to their Leadership Team regarding transformational leadership. They wanted to have a better understanding of what makes an organization...
Here I provide some key summaries and considerations relative to FDA’s draft guidance that was submitted for review and comment in June 2017. If you don’t want to review the entire guidance, here are...
Quality & Compliance
A survey of FDA Form 483 observations issued to the 503B pharmacy industry reveals that outsourcing compounders are struggling to implement and manage compliant and risk-based approaches to aseptic...
What Should Be on Your Clinical Trial Investigator Site Audit Checklist?: You live and operate in a regulated industry. Obviously, it’s crucial that you stay in compliance during your clinical...
Quality & Compliance
In 2016, the FDA issued hundreds of 483 observations across the Drug and Device industries for failing to thoroughly review or investigate issues. This topic consistently hits the top five most...
The FDA’s focus on data integrity in recent years has proven that it remains an industry issue. The focus has resulted in significantly increased issuance rates of 483 observations, warning letters,...
Quality & Compliance
Data integrity has recently been in the agency spotlight. In part because of the draft data integrity guidance issued April 2016, but primarily due to an increased number of inspection findings...
Quality & Compliance
The landscape of clinical trials is evolving. The changes that are happening are due to the increased number of FDA-regulated trials, as well as a rise in the complexity of clinical protocols. As...
Quality & Compliance
At the beginning of each year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. Image Source: FDA I find that reviewing these metrics provides a...
On Wednesday, February 15th, Senators Michael Bennet (D – CO) and Johnny Isakson (R – GA) introduced a bill to improve FDA’s medical device inspection process. If passed, the bill would amend the...
Quality & Compliance
The desire for a robust and repeatable manufacturing process is shared by every organization that has a therapy or product in development and the only way to demonstrate that this desired state has...
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...
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...
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...
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...
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....