FDA Policy/General
Federal Register notice: FDA is updating its records to reflect five recent Emergency Use Authorizations (EUAs) for drug and biological products for use during the Covid–19 pandemic. FDA issued EUAs to: Baxter for Regiocit; HHS for Covid–19 convalescent plasma; , Eli Lilly for bamlanivimab; Regeneron Pharmaceuticals for casirivimab and
Drugs
Pfizer and BioNTech have submitted new stability data to FDA to permit their Covid-19 vaccine vials to be stored at warmer temperatures than their original authorization allowed for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer. The data demonstrate
Devices
FDA has issued a safety alert on the limitations of pulse oximeters. “While pulse oximeters may be useful for estimating blood oxygen levels, these devices have limitations that can result in inaccurate readings,” the agency says. It adds: “Patients with conditions such as Covid-19 should not rely solely on
Devices
FDA has cleared an FX Shoulder 510(k) for the Easytech Stemless Anatomic, a shoulder prosthesis featuring primary peripheral fixation. The device’s design and Easytech Anchor base allows it to fit peripherally just inside the cortical bone where bone quality is optimal for fixation, the company says. It is
Drugs
An FDA study of refuse-to-file (RTF) letters found that 4% of CDER submissions from 2008 to 2017 were issued an RTF. “Overall, 84.5% (544 of 644) of the refusal reasons were for scientific deficiencies; most reasons were related to drug efficacy and safety (196 [30.4%]) and
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Certification To Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)” (OMB Control Number 0910–0616). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget. They are: * Infant Formula Recall Regulations * State Petitions for Exemption from Preemption * Product Jurisdiction and Combination Products * Exceptions or Alternatives to Labeling Requirements for Products Held by the
FDA Policy/General
Although the CDER Office of Prescription Drug Promotion (OPDP) issued fewer enforcement letters in 2020 than in 2019, two Arnall Golden Gregory attorneys say they see little change in enforcement policy or practices in 2021. Their analysis finds that OPDP “will continue to focus its enforcement energies going after false
Devices
FDA has approved Additive Orthopaedics’ Patient-Specific Talus Spacer, a first in the world and first of its kind 3D-printed talus implant for humanitarian use to treat avascular necrosis (AVN) of the ankle joint. An agency statement says the implant “provides a joint-sparing alternative to other surgical interventions
Devices
AdvaMed says that changes in testing requirements for electromagnetic compatibility (EMC) of medical devices should be made with advance notice and appropriate phase-in periods. In comments on an FDA draft guidance, Electromagnetic Compatibility of Medical Devices, AdvaMed says recent changes in testing requirements for in vitro diagnostic (IVD) instrumentation
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Expedited Programs for Serious Conditions — Drugs and Biologics” (OMB Control Number 0910-0765). The collection supports agency regulations and associated guidance that establish procedures designed to expedite the development, evaluation, and marketing of new therapies intended to
Devices
FDA has approved expanded MRI labeling for Medtronic’s InterStim II and InterStim Micro sacral neuromodulation (SNM) systems that use SureScan MRI leads. The updated MRI labeling allows for a wider range of MRI scan parameters and shorter wait time between MRI scans, the company says, adding that it applies
Drugs
Astellas and Seagen say they have completed submitting two sBLAs for Padcev (enfortumab vedotin-ejfv). The companies say that one submission, based on the Phase 3 EV-301 trial, seeks to convert Padcev’s accelerated approval to regular approval. The second submission, based on the pivotal trial EV-201’s
FDA Policy/General
Federal Register notice: FDA is seeking comments on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions on certain drug substances. The comments received in response to the notice will be considered in preparing the U.S.’s position on these proposals for an April meeting
Biologics
FDA says that in response to a section of the 21st Century Cures Act on developing standards for regenerative medicine therapies, it is facilitating efforts to coordinate such standards development. In an online notice, the agency says it has awarded an annual contract to Nexight Group and the Standards Coordinating
Devices
FDA’s Circulatory System Devices Panel has voted not to recommend approval of BD’s Lutonix drug-coated balloon PTA (percutaneous transluminal angioplasty) catheter for treating below-the-knee lesions in patients with critical limb ischemia. Panel members voted 15 to 2 in support of the device’s safety, 2
FDA Policy/General
Federal Register notice: FDA is seeking public comments on an information collection extension associated with its “Guidance for Industry and FDA Staff — Class 2 Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle” (OMB Control Number 0910–0594)— Extension. The collection is authorized
Devices
Three SheppardMullins attorneys say a recent Federal Trade Commission (FTC) settlement highlights the importance of accurately describing how information is collected, used, and shared in digital health apps. In an online FDA Law Update Blog post, the attorneys say FTC settled with Flo Health, Inc., a fertility-tracking app, based
Devices
A 2/10 CDRH virtual town hall answered questions about the development and approval of SARS-C0V-2 (Covid-19) diagnostic tests. Office of In Vitro Diagnostics and Radiologic Health director Timothy Stenzel and associate director Toby Lowe fielded questions on issues including: * transferring ownership of an emergency use authorization;
FDA Policy/General
Federal Register notice: FDA has determined that Arbor Pharmaceuticals’ Nymalize (nimodipine) oral solution was not withdrawn from sale due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs for this reference product if all other legal and regulatory requirements are met. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has announced a 4/15 meeting of its Cellular, Tissue and Gene Therapies Advisory Committee. The panel is scheduled to discuss a CellTrans BLA for donislecel (purified allogeneic deceased donor pancreas derived islets of Langerhans), indicated for treating brittle Type 1 diabetes mellitus. The morning session
Drugs
CBER director Peter Marks says FDA is looking for ways to encourage cancer therapies to evolve quickly with enough information coming to the agency that it can be sure that patients are safe while still not holding back development. Marks spoke on a panel at a virtual meeting sponsored by