Latest Federal Register Notices
Class 2 for Automated Glycemic Controllers
3/11/2022 Federal Register notice: FDA has classified the interoperable automated glycemic controller into medical device Class 2 (special controls). The action is in response to a Tandem Diabetes Care de novo classification request for its Control-IQ Technology. The agency has identified it as a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. It says interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. They are also to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control, it says. To view the notice, click here.
Draft Guide on Drug Supplier Verification Systems
3/10/2022 Federal Register notice: FDA has made available a revised draft guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The document addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act. Specifically, it discusses the statutory verification system requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate. The guidance also addresses the statutory requirement for notification to the agency about a product that has been cleared after a suspect product investigation. To view the notice, click here.
Oncologic Panel Meeting to Review Ukoniq sNDA
3/10/2022 Federal Register notice: FDA has announced a 4/21-22 Oncologic Drugs Advisory Committee meeting. On 4/21, the panel will discuss the appropriate approach for phosphatidylinositol-3-kinase inhibitors currently under development for use in patients with hematologic malignancies and whether randomized data should be required to support a demonstration of substantial evidence of effectiveness. On 4/22, the committee will discuss a TG Therapeutics supplemental NDA for Ukoniq (umbralisib) tablets, and its BLA for ublituximab injection — both submitted for combination use in treating adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. In addition, it will discuss the existing umbralisib accelerated approval indications in patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma. To view the notice, click here.
Quality Metrics Comments Sought on New Direction
3/9/2022 Federal Register notice: FDA has created a docket to receive comments on changes to the agency’s previously proposed quality metrics reporting program. The agency is considering revamping the program based on lessons learned from two 2018-announced pilot programs with industry, a site visit program, and stakeholder feedback on a 2016 revised draft guidance entitled “Submission of Quality Metrics Data.” FDA has also included specific questions on which it seeks comments to help steer the proposed direction for the program. To view the notice, click here.
FDA Updates Covid-19 Guidance Listing
3/7/2022 Federal Register notice: FDA has updated its listing of guidance documents on the Covid–19 public health emergency. FDA notes that the documents were implemented without prior comment, but they remain subject to comment under the agency’s good guidance practices. To view the notice, click here.
2 EUAs Revoked on Covid-19 Tests
3/7/2022 Federal Register notice: FDA has revoked the Emergency Use Authorizations (EUAs) issued to Bio-Rad Laboratories for the BioPlex 2200SARS–CoV–2 IgG, and Quotient Suisse SA for the MosaiQ Covid–19 Antibody Magazine. The agency revoked EUA for the BioPlex device because it was never commercialized, and the EUA for the MosaiQ device because it is no longer being commercially supported. To view the notice, click here.