Latest Federal Register Notices

Device User Fee Rates for FY 2022
7/30/2021 Federal Register notice: FDA has set the medical device user fee rates for fiscal year 2022. The standard fees are as follows: PMA or efficacy supplement ($374,858); panel-track supplement ($281,143); de novo classification request ($112,457); 180-day supplement ($56,229); real-time supplement ($26,240); and 510(k) premarket notification submission ($12,745). To view the notice, click here.

Antimicrobial Panel to Discuss Takeda NDA
7/30/2021 Federal Register notice: FDA has announced a 10/7 Antimicrobial Drugs Advisory Committee meeting. It is scheduled to discuss a Takeda Pharmaceuticals NDA for maribavir oral tablets for treating adults with post-transplant cytomegalovirus infection, including infections resistant and/or refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet. To view the notice, click here.

Biologic Samples/Protocols Requests Extension
7/30/2021 Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Request for Samples and Protocols” (OMB Control Number 0910-0206). The collection supports agency regulations giving it the responsibility to prescribe standards designed to ensure the safety, purity, and potency of biological products and to ensure that the biologics licenses for such products are only issued when a product meets such standards. To view the notice, click here.

eCTD Validations Effective 9/15: FDA
7/29/2021 Federal Register notice: CDER and CBER are announcing the effective date of 9/15 for using Electronic Common Technical Document (eCTD) validations referenced in FDA’s “Technical Rejection Criteria for Study Data.” FDA says that submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process will not be filed or received unless they have an exemption or waiver from the electronic submission requirements. To view the notice, click here.

Efudex Not Withdrawn Due to Safety/Efficacy
7/28/2021 Federal Register notice: FDA has determined that Bausch Health America’s Efudex (fluorouracil) topical solution, 5%, was not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA can continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. The product is indicated for the topical treatment of multiple actinic or solar keratoses, and treatment of superficial basal cell carcinomas. To view the notice, click here.

Guide on Rabies Monoclonal Antibody Cocktails
7/27/2021 Federal Register notice: FDA has made available a draft guidance entitled “Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis.” The document is intended to help sponsors in developing anti-rabies virus monoclonal antibody cocktails as an alternative to anti-rabies virus immunoglobulin as the passive immunization component of post-exposure prophylaxis for preventing rabies when given immediately after contact with a rabid or possibly rabid animal. To view the notice, click here.