USFDA Forms New Board to Guide Drug Exclusivity Grants and Policies
Bengaluru: The US FDA's drug evaluation department said on Friday it has formed a board to oversee and advise on exclusivity determinations made by the department, aiming to improve clarity and consistency of those decisions.
FDA-granted exclusivity rewards innovation by giving newly approved drugs a period of market protection, before lower-cost generic competitors enter the market.
The CDER (Center for Drug Evaluation and Research) exclusivity board will oversee certain exclusivity determinations, including whether and what type of exclusivity should be granted and the appropriate scope of grants, the agency said on Friday
The board will focus on 5-year new chemical entity exclusivity that is granted to a drug whose active ingredient has never before been approved by the FDA
It will also oversee 3-year new clinical trial exclusivity grants that are meant for drugs that use a previously approved active ingredient, but their approval relies on new clinical studies conducted or funded by the sponsor
It will advise on exclusivity for biological products too
The board will not review other types of exclusivity apart from the three, it said
The board also may evaluate and make recommendations regarding CDER's policies and practices relating to exclusivity and maintain records of exclusivity determinations
