Tag Archive
The following is a list of all entries tagged with Data Exclusitity:
Pediatric Exclusivity After Product Approval; FDA Interpriations About Which You Might Not Be Aware
Filed in clinical,regulatory, April 8, 2009, 9:18 amthe FDA grants an additional period of exclusivity for a licensed product for a period of 6 months, if the sponsor submits requested information relating to the use of the active moiety in the paediatric population. There are a number of rules and regulations involved in obtaining this exclusivity
Data Exclusivity Extends Market Protection to 11 years without a patent being required
Filed in regulatory, January 19, 2009, 10:41 amData exclusivity is an important tool in the area of pharmaceuticals and biological therapies, when you successfully apply for a product license in many European countries. This period of data exclusivity was originally implemented to cover areas where patent protection was limited. When a generic application is made for an existing drug, the pre-clinical and [...]
Entries