31 May 2021
DTAB’s decision to maintain the current data exclusivity equilibrium and instead concentrate on evaluating drug protection through bio-equivalence tests is a positive move.
The term “data exclusivity” refers to the protection of data (information) submitted to regulatory authorities or governmental agencies from third-party access. The data, in general, provides information for obtaining marketing clearances for application materials. For instance, a clinical trial report that discloses research trials conducted on people for the assessment of medical or behavioral intervention and is submitted to the government may be in support of a drug application. The information is normally needed to demonstrate the drug’s safety and efficacy.
Article by Manisha Singh and Pankaj Musyuni, 1st published in The Legal Era
For further information, please contact:
Manisha Singh, Partner, LexOrbis
manisha@lexorbis.com
