Devices
FDA has approved a Medtronic PMA for its Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator for treating chronic pain associated with diabetic peripheral neuropathy (DPN). DPN occurs when high blood sugar damages nerves in the body, most often in the legs and feet, leading to numbness and burning or
Drugs
The Southern District of Florida federal court has sentenced former clinical study coordinator Duniel Tejeda to 30 months in prison for his participation in a conspiracy to falsify clinical drug trial data. The court also ordered Tejeda to pay $2.1 million in restitution. According to a Justice Department release,
Devices
FDA has cleared a Biotricity 510(k) for its Biotres Cardiac Monitoring Device, a three-lead holter device for electrocardiogram and arrhythmia monitoring that is intended for lower risk patients. The device, which the company says is designed to address current limitations of existing holter monitors technologies, features three-channel
Devices
FDA has granted Cook Medical a breakthrough device designation for its new drug-eluting stent for below the knee (BTK) use. The new stent is designed to treat patients suffering from chronic limb-threatening ischemia. “This new product leverages our deep understanding of stent design and drug elution for lower
Drugs
The RWE Alliance has suggested that FDA increase communications with external stakeholders about concrete real-world evidence (RWE) use cases. In comments submitted on an FDA draft guidance entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products,
Drugs
Due to effectiveness concerns in treating the Covid-19 omicron variant, FDA has revised Eli Lilly’s emergency use authorization for bamlanivimab and etesevimab and Regeneron’s emergency use authorization for Regen-Cov (casirivimab and imdevimab). Both authorizations have now been limited for use only when the patient is likely
FDA Policy/General
FDA Seeks Comments on Covid Guidances 1/21/2022 Federal Register notice: FDA is announcing recent guidance documents related to the Covid-19 public health emergency. Under emergency procedures, the documents have been implemented without prior comment, but they remain subject to comment in accordance with the agency’s good
FDA Policy/General
Eagle Pharmaceuticals has entered into an agreement to acquire drug formulation and delivery company Arsia Therapeutics for $30 million. Arsia’s technology is designed to allow subcutaneous administration of high-dose biologics. The technology comprises a library of excipients that disrupt interactions between protein molecules without interfering with the proteins
FDA Policy/General
BIOLOGICS FDA has approved an Amgen supplemental BLA for Blincyto (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The company says this indication is approved under accelerated approval, and continued approval may be
FDA Policy/General
Federal Register notice: FDA is announcing recent guidance documents related to the Covid-19 public health emergency. Under emergency procedures, the documents have been implemented without prior comment, but they remain subject to comment in accordance with the agency’s good guidance practices. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Collecting and Providing 702(b) Portions of FDA Official Samples — Questions and Answers. Under Section 702(b) of the FD&C Act, when FDA collects a sample of a food, drug, or cosmetic for analysis, FDA must, upon
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of the Emergency Use Authorizations (EUAs) issued to Cellex Inc. for the Cellex q–SARS–CoV–2 IgG/IgMRapid Test, BioMerieux SA for the SARS–COV–2 R–GENE, Siemens Healthcare Diagnostics Inc. for the Atellica IM SARS–CoV–2 IgG (COV2G)
Drugs
FDA has release a revised guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH). The document provides detailed information and specifications for the content of the tabulated domains and analysis data sets submitted to FDA as part of the sponsor’s NDA
Devices
Medtronic has recalled its HawkOne Directional Atherectomy System due to the risk of the guidewire within the catheter moving downward or prolapsing when force is applied during use. The device comprises a catheter and a cutter driver, and is used during procedures intended to remove blockage from peripheral arteries and
Drugs
FDA has lifted a partial clinical hold on a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML). The hold was the result of the company’s recent report to the agency about a Grade 5 serious adverse event
Drugs
FDA is considering changes to its accelerated approval program, such as international harmonization efforts to “strengthen this approval pathway by considering the differences between expedited programs, including recent innovation by international [regulatory health agencies] RHAs,” according to Oncology Center of Excellence director Richard Pazdur and two other CDER officials. Writing
Drugs
FDA has granted Arch Oncology an orphan drug designation for AO-176 and its use in treating relapsed/refractory multiple myeloma (r/r MM). AO-176 is in Phase 1/2 clinical trials for treating patients with r/r MM, as well as select solid tumors as monotherapy and in
Drugs
FDA has issued Pfizer and OPKO Health a complete response letter for their BLA for somatrogon, an investigational once-weekly long-acting recombinant human growth hormone for treating growth hormone deficiency (GHD) in pediatric patients. Pfizer says it is evaluating the agency’s comments to determine an appropriate path forward.
Drugs
FDA has launched its Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard, an interactive Web-based tool to analyze REMS data in a user-friendly way. An agency announcement says the tool is intended to “expand efficient access to data and report-generating capabilities of REMS programs for healthcare providers,
Devices
The FDA proposed rule on establishing over-the-counter (OTC) hearing aids to implement provisions of the FDA Reauthorization Act of 2017 has drawn praise and recommendations for change from several stakeholders. The Federal Trade Commission commented that it supports the proposed rule “given the benefits to competition and healthcare
FDA Policy/General
Federal Register notice: FDA is seeking comments on its proposal to classify human leukocyte antigen, human platelet antigen, and human neutrophil antigen devices into Class 2 (special controls). The agency says it does not intend to exempt these device types from premarket notification requirements. After considering comments, FDA will publish
FDA Policy/General
Federal Register notice: FDA is classifying retinal diagnostic software devices into Class 2 (special controls). The action is in response to an IDx de novo classification request for its IDx-DR device. The agency has identified these as prescription software devices that incorporate an adaptive algorithm to evaluate ophthalmic images