publication date: Jan. 11, 2019

Drugs & Targets

Gottlieb warns FDA has about one month of user fee funds left

FDA Commissioner Scott Gottlieb has taken to Twitter to say that due to the partial shutdown, the FDA cannot accept new 2019 user fees.

“FDA will continue to advance certain policy, consistent with what’s permissible under law,” Gottlieb tweeted. “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,” he said. “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.”

This lapse in funding, however, may limit medical product related activities. One of those includes the development of certain guidances.

“We cannot accept new applications for medical products that require the payment of user fee.” Gottlieb said.

He clarified the FDA cannot 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 is applicable to submissions that require a payment of a FY19 fee 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, for PDUFA products, the FDA may accept new regulatory submissions that do not require a fee.

The FDA will also not perform “activities with respect to these medical … Continue reading Gottlieb warns FDA has about one month of user fee funds left

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