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Scott Gottlieb, M.D. @SGottliebFDA
, 16 tweets, 4 min read Read on Twitter
THREAD: #FDA will continue to advance certain policy, consistent with what's permissible under law. Carryover user-fees support important actions, including developing guidance and advancing policies that further FDA’s regulatory oversight of medical products and animal drugs.
#FDA will also use carryover funding to support development of medical products. This includes participating in pre-approval discussions with sponsors seeking guidance on how to go forward with clinical research and other ongoing discussions to help advance development programs.
However, this doesn't mean it's business as usual at #FDA; the lapse in funding will limit many medical product related activities, including the development of certain guidances. We also cannot accept new applications for medical products that require the payment of a user fee.
Specifically, #FDA will not be able to accept any regulatory submissions for FY 2019 for new drugs, medical devices, or biologics that require a fee payment and that are submitted during the lapse period, unless the required user fee was paid before December 22, 2018.
This applies to new submissions for which payment of a FY19 fee is required under PDUFA and the Generic Drug User Fee Amendments, Biosimilar User Fee Amendments, Medical Device User Fee Amendments, Animal Drug User Fee Amendments, or the Animal Generic Drug User Fee Amendments.
During the lapse period, for PDUFA products, FDA will accept new regulatory submissions for which no fee is required. These types of submissions include INDs, annual reports, supplements to NDAs and BLAs, submissions that fall within fee exemptions, and general correspondence.
#FDA will accept generic drug submissions for which no fee is required if the product is within the scope of the GDUFA program. These submissions include CBE supplements and prior approval supplements to approved ANDAs, amendments, annual reports, and applications for PET drugs.
FDA will accept DMFs, including Type II API DMFs, intended to be referenced in generic applications. FDA won't conduct initial completeness assessments on Type II API DMFs for which the fee hasn't been paid and these new DMFs will not be placed on the Available for Reference List
Regarding the review of medical products that are not within the scope of any of #FDA’s user fee programs: Certain limited categories of medical products regulated by CDER and CBER are not within the scope of any of FDA’s user fee programs.
Accordingly, fee funding is not available to carry out activities with respect to these limited categories of medical products. For example, within CDER, carryover user fee funding is not available for OTC monograph drug activities.
Similarly, within CBER, work on whole blood, blood components for transfusion, allergenic extract products, and human cells, tissues, and tissue-based products regulated solely under section 361 of the Public Health Service Act cannot be conducted with carryover user fee funding.
During the lapse period, FDA will not perform any activities with respect to these medical products except for emergency work involving the safety of human life or the protection of property.
For example, FDA will continue to conduct surveillance for adverse events to determine the potential risk to health from such products and conduct recalls or take other critical actions to protect the safety of human life.
Additionally, for medical products in these categories subject to premarket approval, FDA will suspend review of any pending regulatory submissions unless the submission is: an emergency IND; or an IND amendment related to the safety of human subjects (e.g. an IND safety report)
If a sponsor sends #FDA a non-emergency IND during the lapse period for a medical product in one of these categories, the 30-day review clock will not start until the lapse period is over.
The only new INDs and IND amendments for these products that FDA will consider “received” (and proceed to review) during the lapse period are: new emergency INDs; and new IND amendments that relate to the safety of human subjects.
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