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computer susteIt’s a Friday afternoon. Quarter’s end. Your V.P. of Regulatory Affairs calls your office bellowing something about not being able to process the latest submission data- can’t access...
Business sustainability is an often heard buzz phrase, but how does it apply when a costly process validation is imminent? Process validation is not only a regulatory compliance issue; it is also a...
Since the day I entered the industry the mantra of “If you didn’t write it down, it didn’t happen” was repeatedly drilled into my daily mode of operation. The margins of my test sheets were filled...
Quality & Compliance
Today, ProPharma's Simona Gherman adds to her series on Media Programs and media fills. Part I of this series was an overview with background information and tips. Part II focuses on what you need,...
Regulatory Sciences
On May 5, 2015, the Food and Drug Administration (FDA) released the final guidance on Providing Regulatory Submissions in electronic format. The guidance implements the electronic submission...
Quality & Compliance
>Would your media program pass the test? The FDA inspection test, that is. In this new blog series, ProPharma Group’s Simona Gherman breaks down the FDA regulatory requirements for a successful media...
If you are like the majority of those who have worked in the biotechnology and pharmaceutical industry for at least the last five years, your company has been part of a merger, acquisition or some...
In a final guidance published in the Federal Register on May 5, FDA laid out the rules and specifications for providing regulatory submissions in electronic format. Perhaps more important than the...
On February 25, 2015, FDA approved Toujeo, a once-daily, long-acting recombinant insulin. A year earlier an inhaled formulation of insulin, Afrezza, was approved. These recent additions to the...
Many active ingredient assay failures can be attributed to weighing and charging errors incurred during the compounding process. Even when the active ingredient is weighed and charged correctly,...
Trying to remain compliant with the current Good Manufacturing Practices (cGMP) has its challenges and opportunities. I would like to discuss the opportunity afforded by the ASTM E2500 "Standard...
Commonly during drug development, significant issues arise for which FDA input is desired but that do not merit a full face-to-face multidisciplinary milestone meeting. In many cases, sponsors are...
A recent analysis by the Tufts Center for the Study of Drug Development places the price tag of bringing a new drug to market at around $2.6 billion. The reason for this is simple: failure. Drugs...
My apologies to you in the technical writing profession out there, but there are not too many topics that are as bland and unappealing as technical writing. Personally, I'd rather step on a sharp...
Moving an operational Quality Control Laboratory is all about maintaining the support of production testing, ensuring physical integrity of the instrumentation being moved, and qualification of the...
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...
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...
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...
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...
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...