FDA CDER Creates Exclusivity Board to Oversee Drug Exclusivity Determinations
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FDA's Center for Drug Evaluation and Research has established an Exclusivity Board to oversee and advise on certain drug exclusivity determinations, with the stated aim of bringing clarity and consistency to the process. The Board's scope covers 5-year new chemical entity exclusivity, 3-year new clinical trial exclusivity, and biological product exclusivity. It generally will not review 180-day generic drug exclusivity, 7-year orphan drug exclusivity, or 6-month pediatric exclusivity. Beyond individual determinations, the Board may also evaluate CDER's exclusivity policies and maintain records of its determinations. Questions about its work can be directed to its FDA email address. What the Board's first determinations will be, and how its policy review will shape CDER practice, have yet to emerge.
Written by a model from the reports · updated 1 day ago
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- fda.govPickCDER Exclusivity Board
FDA's Center for Drug Evaluation and Research has set up an Exclusivity Board to oversee and advise on certain exclusivity determinations, aiming for clarity and consistency. The Board covers 5-year new chemical entity exclusivity, 3-year new clinical trial exclusivity, and biological product exclusivity, but generally will not review 180-day generic drug, 7-year orphan drug, or 6-month pediatric exclusivity. It may also evaluate CDER exclusivity policies and keep records of determinations, and questions can be sent to its FDA email address.
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