Advancements in technology create new avenues for optimizing clinical trials and the lessons that can be learned from them. With the gap between advancements in technology and regulatory uptake in clinical trials, it is important to rigorously examine technology applications. While the promise of new technology can lead to overenthusiastic adoption, mirroring the pace of other industries may not always lead to the best outcomes for patients. To increase regulatory buy-in to the use of these technologies, the clinical trial world needs a thorough understanding of the functionalities of each technical innovation, its potential utility and limitations, and how to build trust among patients, regulators, and other healthcare professionals.
Experts discuss whether compounding pharmacies can help enable iterative development, the feasibility of just-in-time drug manufacturing, and recommendations for speeding materials release.
This article explains the final three components that can be used to establish a compliant disinfectant efficacy testing package in the U.S. along with tips for assembling the package.
Have you noticed that it has become increasingly difficult to transport your material into and out of the United States? That’s because it has!
Much has been written about millennials — how they think, what motivates them, and their outlook on life. How can we best prepare them for today’s pharma/biotech manufacturing environment so they are successful?
The bioprocessing industry is continuing to invest in training as it seeks to avoid problems and capacity constraints. And while budgets are increasing, new practices such as online components, standardization, and the development of accredited/certified training have not been adopted yet.
How can we reduce these risks and increase the success in adopting new technologies and better supply chains? Part of the answer is better collaboration between industry, academia, and government.
While it’s common to say a company has experience with a certain technology, it is the people at that firm who are able to utilize equipment and procedures in successful applications of technology.
When we think of risk in the context of drug development and manufacturing, it is human nature to associate any risk-based approach with adding risk to the decision or process. This guidance laid the foundation for two important concepts that influence how we develop and guarantee the quality of our drug products today.
Last month, FDA issued a Warning Letter to Polydrug Laboratories of Maharashtra, India, stemming from an inspection in March 2015. Certainly, Polydrug has conducted extensive negotiation with the agency since the inspection, and is now feeling the impact of the unresolved deficiencies. However, closer review of the text of the Warning Letter reveals Polydrug was placed on Import Alert in September, 2015, inflicting immediate restrictions on Polydrug’s US revenue.
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