Devices
FDA has cleared a Centinel Spine 510(k) to market its FLX Platform of integrated interbody and non-integrated interbody fusion devices. The 3D-printed, all-titanium devices feature a combination of solid and porous radiolucent sections designed to reduce mechanical stiffness and improve visibility, compared to solid titanium implants,
Drugs
FDA has approved a Cellenkos IND to proceed with a Phase 1 clinical trial of CK0801, third-party cord blood-derived regulatory T cells, in patients with bone marrow failure syndrome including aplastic anemia, myelodysplastic syndrome and myelofibrosis. The trial of CK0801 will begin in the third quarter at the
FDA Policy/General
Mutamycin Not Withdrawn Over Safety/Efficacy: FDA Federal Register notice: FDA determines that Mutamycin (mitomycin) injectable, 5mg/vial and 20mg/vial, was not withdrawn for reasons of safety or effectiveness. 06/11/2018 Correction on Product Classification Proposed Rule Federal Register notice: FDA corrects a 5/15 proposed rule to
Devices
FDA has cleared an Edap TMS 510(k) for its Focal One device for ablating prostate tissue. The high-intensity focused ultrasound device is the “first medical apparatus designed specifically for focal treatment of the prostate,” the company says. “Focal One fuses MR and 3D biopsy data with real-time
FDA Policy/General
Federal Register notice: FDA has corrected a 5/15 proposed rule to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to agency centers for premarket review and regulation. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 6/27 public workshop entitled “Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis.” The workshop is scheduled to discuss clinical trial design challenges and future considerations for inhaled antibacterial products to treat cystic fibrosis (CF) and non-CF
FDA Policy/General
Federal Register notice: FDA has classified the in vivo cured intramedullary fixation rod into Class 2 (special controls). The action was in response to a 2016 request by IlluminOss Medical for a De Novo classification of the IlluminOss Photodynamic Bone Stabilization System. The agency has identified the rod as a
Drugs
Federal Register notice: FDA has announced the renewal of the Pulmonary-Allergy Drugs Advisory Committee for an additional two years. The new charter will be in effect until 5/30/2020. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted a proposed extension for a collection of information on Medical Device Reporting: Electronic Submission Requirements (OMB Control Number 0910-0437). To view the notice, click here.
Devices
TransEnterix has submitted a 510(k) for additional Senhance System instruments, including 3mm diameter instruments. TransEnterix says it is the first company to seek FDA clearance for robotically-driven 3 mm instruments for abdominal surgery in the U.S. Their clearance would allow the Senhance to be used for “scarless”
Drugs
A northern Mississippi judge 6/8 entered a consent decree of permanent injunction against Delta Pharma (Ripley, MS) and two company officials for failing to correct promised deficiencies at the firm’s drug compounding operation. The decree prohibits Delta Pharma and the other defendants from manufacturing, processing, packing, holding or
Devices
Draeger Medical Systems begun a Class 1 recall of its Draeger Jaundice Meter due to a device design flaw. Users have misinterpreted the display for out-of-range measurement indicated by a blinking “0” to mean a zero measurement, a recall notice says. The device is intended for use in
Drugs
FDA has approved a Celixir IND for Heartcel, an immuno-modulatory progenitor (iMP) cell therapy for treating adult heart failure. The tissue-engineered product comprises allogeneic (off-the-shelf) iMP cells, which are a novel cell type engineered to reduce heart scarring and regenerate the heart in patients with heart
FDA Policy/General
FDA has approved an AbbVie’s Venclexta (venetoclax tablets) in combination with rituximab for treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. Approval is based on MURANO Phase 3 clinical trial data which demonstrated
Devices
Maquet Datascope has recalled its CardioSave Hybrid Intra-aortic Balloon Pump due to a design issue that allows fluid (e.g., saline) to seep into the device. The fluid can corrode internal components (electronic circuit boards) that could lead to device malfunction and a delay or interruption of therapy, according
FDA Policy/General
Federal Register notice: FDA has published modifications to its list of standards the agency recognizes for use in premarket reviews (FDA Recognized Consensus Standards). The publication is entitled “Modifications to the List of Recognized Standards, Recognition List Number: 049” (Recognition List Number: 049) and will assist manufacturers who elect to
Drugs
CDER director Janet Woodcock says management of the Center’s formal dispute resolution (FDR) program is being transitioned from the immediate office of the Office of New Drugs to the Office of Executive Programs. “This transition allows Center-level management of the FDR program, which is not only used by
Drugs
FDA commissioner Scott Gottlieb says that a Biotech Working Group named last month is preparing an action plan with steps the agency will take to ensure it has a flexible regulatory framework for evaluating the safety of products that also supports plant and animal biotechnology innovation. Gottlieb made the comment
Drugs
The HHS Office of Inspector General (OIG) says FDA computed PDUFA rates paid by drug companies accurately. An OIG audit report says the office obtained and reviewed documentation from FDA such as policies and procedures and financial records to determine whether it accurately computed prescription drug user fee rates. It
Devices
FDA has cleared a K2M Group Holdings 510(k) for its Ozark Cervical Plate Systems for anterior screw fixation to the cervical spine (C2-T1) in patients with degenerative disease, deformity, tumor, or trauma. The systems are available in two designs, Ozark Guide and Ozark View, both featuring an advanced
Devices
A 5/24 CDRH Webinar on two precision medicine guidances outlined major changes between the 2016 draft guidances and the final documents issued 4/13. During the Webinar, Adam Berger from the CDRH precision medicine staff, said the scope of the final guidance on design, development, and analytical validation of
Drugs
The Association for Accessible Medicines (AAM) and its Biosimilars Council says FDA should take a case-by-case approach in determining whether a 505(b)(2) biological product is deemed to be a 351(a) or 351(k) biologic. AAM says this should be an administrative transition so products can