With attention shifting to data integrity, companies must increasingly be able to guarantee the reliability and accuracy of their quality data. To do otherwise could leave companies vulnerable to data integrity and quality risks that increase their chances of noncompliance.
There are many different chemical ways of combating overdose, but researchers have identified three primary categories of biologic therapy for treating drug addiction and abuse: vaccines, monoclonal antibodies, and genetically modified enzymes.
Companies can prepare to compete with biosimilars by adopting a simple, yet effective, strategy: innovation. By developing drugs that improve upon earlier iterations, companies can continue to protect their market advantage from lower-cost generic versions.
There is a growing need for more efficacious retinal degenerative disease treatment as the population ages and there is mounting exposure to common causes.
These latest TSCA reform efforts reflect a current trend among federal agencies to increase regulatory oversight of commercial industries. Failing to comply with new standards can be costly and, in some cases, deadly.
Following the explosion of biomedical understanding over the last few decades, researchers have begun to develop biologic therapies for diseases. Understanding the biologics regulatory pathway will help researchers utilize emerging technology while ensuring that their new therapies meet necessary standards at every step of the process.
There is a growing body of research highlighting the unique properties of cancer stem cells and scientists can use this information to design biologic drugs that exploit CSC properties in order to provide more effective treatment strategies for cancer.
Nanocarriers may be able to deliver medication for a variety of mental and neurological disorders, which will be a breakthrough for many drug-resistant and otherwise untreatable illnesses.
The FDA approved an active hemostatic agent called Raplixa for use in surgery in April 2015. Hemostatic agents may be considered either mechanical or active. Mechanical agents prevent bleeding by forming a mechanical barrier, whereas active hemostats contain active biological materials.
Cancer cells are often present in the body without ever turning into full-blown cancer. In theory, the body has natural mechanisms which seek out and destroy cancer cells. It truly becomes “cancer” when cancer cells are able to evade immune detection and destruction, and set up camp within the body. […]