Devices
Abbott has recalled its Ellipse Implantable Cardioverter Defibrillators (ICDs) after electrical failures had been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed. This makes them prone to electrical shorting of the capacitor, a recall notice says. If a short
Drugs
Draft Guide on Clin-Pharm Considerations for Neonatals Federal Register notice: FDA makes available a draft guidance entitled “General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products.” 08/02/2019 Nonclinical Toxicology Studies Q & A Draft Guide Federal Register notice: FDA makes available a draft guidance
FDA Policy/General
Otsuka Pharmaceutical and Medimetriks Pharmaceuticals have entered into a licensing agreement granting Medimetriks exclusive development and commercialization rights for a topical non-steroidal phosphodiesterase IV inhibitor, OPA-15406, in the U.S. and Puerto Rico for treating atopic dermatitis. According to the companies, OPA-15046 demonstrated clinically significant results vs.
FDA Policy/General
BIOLOGICS FDA has approved the composition of Protein Sciences Corp.’s Flublok influenza vaccine for the 2015-16 flu season. The company says there are two strain changes this year. DEVICES FDA has cleared a Cardiovascular Systems 510(k) for its ViperWire Advance Peripheral Guide Wire with Flex Tip for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products.” The document was mandated under the FDA Reauthorization Act of 2017 (FDARA). To view the notice, click here.
Devices
FDA has cleared a Medicrea Group 510(k) for its Tulip Genesis for use with the UNiD Adaptive Spine Intelligence platform technology. Tulip Genesis is described by Medicrea as a state-of-the-art comprehensive top loading screw system that offers solutions for both degenerative and complex deformity spinal cases.
Drugs
FDA has allowed Momenta Pharmaceuticals to proceed under its IND to begin an adaptive Phase 2/3 clinical study for its FcRn inhibitor nipocalimab (M281) in warm autoimmune hemolytic anemia (wAIHA). If successful, the adaptive Phase 2/3 study could serve as a pivotal study which could enable nipocalimab to
Drugs
FDA has approved a Daiichi Sankyo NDA for Turalio (pexidartinib) capsules for treating adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. TGCT is a rare tumor that affects the synovium (thin layer of tissue that
Devices
Qiagen has recalled filter tips used with the QIAsymphony SP/AS instruments due to their potential to leak, which may result in delayed or inaccurate results. The pipetting system filter tips are used for clinical assay workflows or with in vitro diagnostic tests. “Due to a manufacturing malfunction resulting in
Devices
Teleflex has recalled certain Sheridan endotracheal tubes and connectors, which are also used in Centurion’s convenience kits. “Teleflex recalled multiple models of the Hudson RCI Sheridan and Sheridan endotracheal tubes due to reports of the Sheridan endotracheal tube connector dislodging from the endotracheal tube, causing disconnection of the patient
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers.” The document is intended to address documentation practices during pathology peer review, which FDA says have not been clearly defined and vary among nonclinical testing facilities. To view the
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Bacterial Vaginosis: Developing Drugs for Treatment.” The document is intended to assist sponsors in the clinical development of such drugs. Changes incorporated in the final guidance include clarification about the timing of the primary efficacy endpoints, which are based
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (determined by an FDA-approved test) with disease progression after one or more prior lines of systemic therapy. Approval was based on data
Drugs
FDA has published a final guidance, Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations, to give sponsors information on the design of an appropriate nonclinical program for developing radiopharmaceuticals to treat cancer, also known as oncology therapeutic radiopharmaceuticals. The document also contains recommendations for certain aspects of product labeling. The
FDA Policy/General
Federal Register notice: FDA has set the prescription drug user fee rates for fiscal year 2020. They are: Application requiring clinical data ($2,942,965), application not requiring clinical data ($1,471,483); and program fee ($325,424). To view the notice, click here.
Devices
FDA has granted B. Braun Interventional Systems a breakthrough device designation for the SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty balloon catheter for treating coronary in-stent restenosis. SeQuent is the latest generation coronary drug-coated balloon catheter developed by B. Braun. The company says the designation is
Drugs
FDA has issued a draft guidance, Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers, with information for sponsors and nonclinical laboratory staff about the management and conduct of pathology peer review performed during good laboratory practice-compliant toxicology studies. “When conducted, pathology peer review should be well-documented,
Devices
FDA has issued a draft guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, with the agency’s recommendations on testing to assess the safety and compatibility of medical devices in the magnetic resonance environment. The document also has the recommended format for magnetic resonance
Drugs
FDA has issued a final guidance, Bacterial Vaginosis: Developing Drugs for Treatment, to assist sponsors in the overall development program and clinical trial designs to support development of topical and systemic drugs and biological products for treatment of bacterial vaginosis. The document focuses on considerations that are specific to bacterial
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “E8(R1) General Considerations for Clinical Studies.” The International Council for Harmonization document describes internationally accepted principles and practices for designing and conducting drug/biologic clinical studies. In addition, it addresses the types of clinical studies that may be
Devices
FDA and France’s Dassault Systèmes will extend their collaborative research agreement for five years with an aim to spur medical device innovation by enabling innovative, new product designs. The company says its 3DEXPERIENCE platform “will be used to develop a new digital tool to enable more efficient regulatory review
Drugs
FDA has expanded the approval for Leo Pharma’s Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older. The agency also granted Enstilar Foam pediatric exclusivity, extending it by an additional six months to 12/