As pharmaceutical products have become more complex, many companies have become bogged down in accomplishing their primary mission of launching new products by complex regulatory requirements, convoluted management approaches, and inefficient resources and methods that add time and cost to moving new products from research to the patients.
COVID-19 has caused an increase in demand for APIs and drugs; those used as antimalarials are seeing the highest demand, followed by bronchodilators, antibiotics, and antivirals. This article reviews the drugs and API in demand globally, with assessments of their supply status in India and China.
Although the benefits of implementing it in clinical studies are evident, patient technology has yet to make a clear entrance into the clinical arena, as many trials continue to rely on traditional research methodology.
During a recent Halloran Virtual Town Hall meeting, a panel of experts to share what they are seeing in terms of regulatory activity, as some cases are receiving expedited feedback, while others are experiencing delays in reviews and receipt of commentary from the FDA. This article presents some key insights from the panel’s experience conducting regulatory activities during the pandemic.
During this COVID-19 pandemic, we have all heard it: Wash your hands with soap and water for at least 20 seconds. This article focuses on transferring basic aseptic techniques and good hygiene practices learned in the pharmaceutical industry to help you dodge the COVID-19 bullet.
Any time a contractor or CMO is used, including arrangements between different divisions of the same company, regardless of the location of the parties involved, there should be a quality agreement in place.
This article describes a practical risk-based approach for assessing and identifying the surfaces, areas, or sites of manufacturing and packaging equipment that are cleaned upon completion of oral solid dosage manufacturing production.
While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.
We must change the way we think. We must stop perceiving our processes as separate from the current supporting and related downstream technology. We must begin to consider and care as much about how our data will be used or interpreted as we do about how we create it.
It is important to understand why risk-based monitoring (RBM) alone is not enough for a trial to succeed and what the industry can do to extend the use of risk-based strategies to ultimately support improved data quality and increased patient safety in clinical trials.