Bringing new drugs to market takes more than just testing. Among the hurdles is filing the drug’s product information properly with the Food and Drug Administration (FDA).
Health Science Funding was trying to bring to market a new lupus treatment drug called Prastera. Because the product is a kit containing only drugs already allowed to be marketed by the FDA, the first step was to get the drug’s product information listed with the FDA through a process called Structured Product Labeling (SPL). Health Science Funding turned to a registration company working in that area but ran into a number of delays with having the product labeling done correctly. After nearly a year of trying, the drug’s SPL information was only partially listed, so the drug was still unavailable to patients.
Health Science Funding decided to turn to Data Conversion Laboratory. Health Science Funding’s project manager Mark Pohl says he was immediately impressed with DCL’s prompt response to his inquiry, and even more impressed with the swiftness and ease in its ability to quickly identify the issues he was facing with the FDA. Almost immediately, DCL worked with the company to correct those issues.
Pohl says, “DCL was so efficient that they were able to identify SPL submission issues before they happened. They then worked with me to prepare for those issues, which helped the process move even faster.”
As a result, Prastera’s SPL information was submitted and listed within a month and is being prescribed to patients. Pohl says his company is working on an improved version of the drug and will turn to DCL again to make sure it gets to market as soon as possible.
Read the entire article on KMWorld.com.