Drugs

NDA/ANDA User Fee Acceptance Dates for Shutdown Filings

An FDA notice says that for NDAs and BLAs transmitted to the agency during the partial government shutdown, sponsors will have a five-day window (until 2/1) to pay the required user fee. If the fee is paid within that five-day period, the receipt date will be the first business day after FDA reopened (1/28). If the fee is not paid within this window, then the receipt date for the submission will be set to the date on which that liability is satisfied.

For ANDAs transmitted during the shutdown, sponsors will have a 20-day window (until 2/18) to pay the user fee. If the fee is satisfied within that 20-day period, then the receipt date will be set at 1/28. “If the fee is not satisfied within that 20-day period and the ANDA is found to otherwise meet the criteria for receipt, the receipt date for the submission will be set to the date on which that liability is satisfied,” FDA says.

FDA notes that if a user fee was transmitted during the shutdown period (check or wire transfer), then the agency held the payment until it could accept it on the first business day after the shutdown ended (1/28). lapse period ended. “Therefore, fee incurring submissions transmitted to FDA during the lapse period are treated as though they had been transmitted on the first business day that the FDA was once again authorized to accept FY 2019 user fees for those submissions, i.e., 1/28/2019,” it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome