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Those of you in the pharmaceutical, biotech and medical device industries who encounter process and product problems on a regular basis, you likely grimace when one lands in your lap. There is a...
As Phase I clinical trials mark the first time that an investigational new drug is administered to humans, these studies are subject to appropriate current Good Manufacturing Practices (cGMP) in...
On May 10th the Food and Drug Administration (FDA) published a final rule expanding regulation to a range of products that meet the statutory definition of a “tobacco product,” including...
Implementing and maintaining a Quality System is a complex challenge. It is as much as an art as it is a science. A company’s Quality System establishes the framework to manage and maintain...
For those of you unaware, the FDA submitted a draft guidance on data integrity for comment in April. This is significant in that the last formal written guidance provided from FDA on this subject...
In today’s validated lab environment, knowing the importance of an audit trail in computerized laboratory systems is just one of the integral qualification tasks that the ProPharma’s Computer System...
In September 2007, the Prescription Drug User Fee Act (PDUFA IV) was reauthorized and expanded, broadening and strengthening FDA’s drug safety program. As part of PDUFA’s reauthorization, the Agency...
At the time of this writing, there were 59 registered 503b outsourcing facilities posted on the FDA’s website. All firms that had been inspected were issued FDA inspectional observations in the form...
As we’ve now moved on from another cold winter month, I was captivated recently thinking about Quality Assurance and our collective responsibilities. All kinds of things come to mind; Deviations,...
Data integrity is a current hot topic, but not a new one, within the life sciences industries and associated product supply chains. This article will not delve into why there have been so many recent...
Quality & Compliance
Starting with the issuance of a 483, the stepwise FDA enforcement process can be illustrated as follows: Given the seriousness of a Seizure and Injunction scenario, not to mention potential jail time...
The Food and Drug Administration Safety and Innovation Act (FDASIA), was signed into law on July 9, 2012. This law significantly expanded the FDA’s authority and strengthened its ability to safeguard...
If you’ve spent a reasonable amount of time in an FDA-regulated industry, you’ve most likely been part of an FDA inspection. Should you be more fortunate, you have participated directly with the...
Compensating Controls: “A safeguard or countermeasure, external to the device, employed by a user in lieu of, or in the absence of sufficient controls that were designed in by a device manufacturer,...
Over the past several years, outsourcing within the pharmaceutical supply chain has become common. The rise of the “virtual” pharmaceutical company has resulted in a complex supply chain, with 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...