US FDA sets up board to oversee drug exclusivity determinations

Oct 16 (Reuters) 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. Here are more details: • 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 r