FDA provides more details on shutdown policies

FDA on Friday released more details on product reviews during the government shutdown. The agency said it does "not anticipate that the lapse in appropriations will affect our routine product review process for submissions within the scope of the PDUFA or GDUFA programs, provided that applicable fees were paid before October 1, 2013." However, FDA added that it "cannot predict whether we will experience delays in these programs in the event of a protracted lapse in appropriations." The agency expects to hold advisory committee meetings related to product approvals during the shutdown.

FDA said it will not accept NDAs or BLAs if the PDUFA fee was not submitted prior to Oct. 1, though the agency said it will continue to accept submissions "within the scope of the PDUFA program" that do not require fees, including NDAs or BLAs with Orphan designated indications or with small business fee waivers. FDA said it will continue to accept INDs and manufacturing and labeling supplements to NDAs and BLAs. ...