Day: July 30, 2015

The FDA has finalized a new guidance recommending continuous refinement of analytical procedures and methods validation over the lifecycle of drug products based on new information collected over time. These recommendations will be additional to drug product quality documentation requirements that are standard during application for market approval or when there is change in the manufacturing process. … Read more

A recent report by two patent law professors, one from the US and one Denmark, raised concerns that reporting of detailed clinical trial information, as required under the current laws, could adversely affect the patentability of new uses of drugs. Analysis of full clinical trials data may reveal novel indications not previously known or obvious, making it … Read more

We consume a lot of drugs and they all end up polluting the environment. Human waste, urine and feces, are the primary sources of drugs found in wastewater and sewage from where it ends up into water bodies such as streams, rivers, lakes, seawater, and eventually, drinking water. FDA has several rules requiring companies to … Read more