Newsletter - July 30, 2015
High Levels of Drugs Found in Water Supplies World-Wide
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 control environmental exposure of drugs from the manufacturing sites, and for the last 20 years has required inclusion of environmental assessment in market approval applications. Read More...
Will Clinical Trial Data Sharing Hurt Innovation?
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 difficult to patent a further, significant use of the drug at a later date. Due to lack of patentability, the new application may not be developed. It is widely accepted that sharing of detailed data from clinical trials would increase transparency, reduce redundancy, and improve the overall efficiency of clinical research. Read More...
FDA Requires Drug Companies to Update Analytical Procedures as Part of Life-Cycle Management
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. Currently, each NDA, BLA and ANDA must include the analytical procedures necessary to ensure the identity, strength, quality, purity, and potency of both the drug substance and drug product along with data demonstrating that the procedures used meet proper standards of accuracy, sensitivity, specificity, reproducibility and suitability for their intended purpose. Read More...
High Levels of Drugs Found in Water Supplies World-Wide
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 control environmental exposure of drugs from the manufacturing sites, and for the last 20 years has required inclusion of environmental assessment in market approval applications. Read More...
Will Clinical Trial Data Sharing Hurt Innovation?
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 difficult to patent a further, significant use of the drug at a later date. Due to lack of patentability, the new application may not be developed. It is widely accepted that sharing of detailed data from clinical trials would increase transparency, reduce redundancy, and improve the overall efficiency of clinical research. Read More...
FDA Requires Drug Companies to Update Analytical Procedures as Part of Life-Cycle Management
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. Currently, each NDA, BLA and ANDA must include the analytical procedures necessary to ensure the identity, strength, quality, purity, and potency of both the drug substance and drug product along with data demonstrating that the procedures used meet proper standards of accuracy, sensitivity, specificity, reproducibility and suitability for their intended purpose. Read More...
