FDA to host public hearing regarding the implementation of GDUFA
SILVER SPRING, Md. — The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities. Requests to make oral presentations at the hearing are due Sept. 3.
The five draft guidance documents include:
Abbreviated new drug application submissions, including content and format of ANDAs;
Guidelines on the refusal to receive submissions for lack of proper justification of impurity limits;
Amendments and easily correctable deficiencies under GDUFA;
Prior approval supplements under GDUFA; and
Controlled correspondence related to generic drug development.
Another purpose of the hearing will be to solicit feedback on issues that may arise in FDA’s consideration of 180-day exclusivity provided for in section 505(j)(5)(B)(iv) of the FD&C Act, the agency announced. "Timing of ANDA approval is directly affected by an applicant’s eligibility for 180-day exclusivity, and thus FDA’s consideration of any issues related to 180-day exclusivity is a component of approval actions," the agency stated. "FDA decisions regarding 180-day exclusivity are fact-specific, and the facts that have the potential to determine eligibility for exclusivity may shift up to the time when an ANDA that is eligible for 180-day exclusivity, or another ANDA referencing the same listed drug, is ready for approval."