Devices
FDA has qualified the OsiriX CDE software module from the TBI Endpoints Development Initiative as the first biomarker test tool type to be qualified. The agency says it is the third medical device development tool (MDDT) it has qualified. The qualification is said to provide a tool for more efficient
Drugs
FDA has approved Regeneron Pharmaceuticals’ Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids, the company
Devices
Integra LifeSciences says that a subsidiary 3/6 received an FDA Warning Letter blocking PMA approvals due to quality systems issues at a Boston manufacturing facility. The facility manufactures extracellular bovine matrix products. The letter was based on finding from a 11/2018 inspection and mirrored Form 483 observations that
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Export of Medical Devices; Foreign Letters of Approval” (OMB Control Number 0910-0264). Written authorization must be obtained from the appropriate office within a foreign government approving the importation of a medical device. An alternative to obtaining written
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Center for Devices and Radiological Health Appeals Processes” (OMB Control Number 0910-0738). The agency guidance describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. FDA is seeking
FDA Policy/General
Federal Register notice: FDA has made available a model Drug Facts label for nonprescription naloxone, indicated for treating opioid overdose. The agency is making the label and supporting data available for use by applicants seeking approval for naloxone drug products that can be obtained without a prescription. To view the
Drugs
The Trump Administration has proposed a 7% boost ($419 million) in FDA’s 2020 budget, which includes more than $220 million to continue advancing new initiatives that will promote medical product innovation. An agency release says that the additional resources would “help the agency combat the opioid epidemic; advance new
Drugs
CytoDyn says it is seeking fast track status for its humanized CCR5 monoclonal antibody, leronlimab (PRO 140), after it showed a significant reduction in the volume of human breast cancer tumor metastasis in a murine xenograft model. “The metastatic tumor volume was reduced by more than 98% after seven weeks,
Devices
FDA has granted Alcyone Lifesciences a breakthrough device designation for its ThecaFlex DRx System, an implantable subcutaneous port and intrathecal catheter used to provide access for cerebrospinal fluid aspiration and therapy infusion (intrathecal bolus administration). The company says the device is indicated for patients aged three years and above who
FDA Policy/General
Comments Sought on Info Collection for CDRH Appeals Federal Register notice: FDA seeks comments on an information collection extension for “Center for Devices and Radiological Health Appeals Processes.” 03/08/2019 New Info Collection on Bio Product Name Suffix Federal Register notice: FDA seeks comments on a new information collection
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Center for Devices and Radiological Health Appeals Processes” (OMB Control Number 0910-0738). The agency guidance describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. FDA is seeking
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection for “Proposed Suffix for the Proper Name of a Biological Product.” The collection is related to a final guidance on “Nonproprietary Naming of Biological Products,” which recommends that applicants propose a suffix composed of four lowercase letters to
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Nonproprietary Naming of Biological Products: Update.” The document describes FDA’s current thinking on biologic product nonproprietary names that do not include an FDA-designated suffix. Specifically, the nonproprietary names of these products need not be revised to accomplish
FDA Policy/General
FDA is seeking comments on a new information collection related to a proposed “Healthcare Professional Survey of Professional Prescription Drug Promotion.” The survey’s goal is to learn healthcare professionals’ (HCPs) opinions on promotional materials and procedures targeted at HCPs, clinical trial design and knowledge, and FDA approval status. Additionally,
Devices
FDA has issued a letter to health care providers to alert them to an increasing number of medical device reports associated with surgical staplers for internal use and implantable surgical staples. In the coming months, CDRH will issue a draft guidance with safety labeling recommendations for manufacturers, according to a
Drugs
American Health Packaging has recalled one lot of valsartan tablets,160 mg , due to the detection of trace amounts of an unexpected carcinogen in the finished drug product. The impurity is N-Nitrosodiethylamine, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes,
Devices
FDA has cleared a Zeiss Medical Technology 510(k) for the Cirrus HD-OCT platform, expanding the capabilities of its anterior segment premier module to include epithelial thickness mapping. The device is designed to provide a detailed nine-millimeter map of epithelial thickness for assessing patients before refractive surgery, the
Drugs
FDA has granted Genentech accelerated approval for Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for treating adults with unresectable locally advanced or metastatic triple-negative breast cancer in people whose tumors express PD-L1. Approval was based on data showing favorable
Drugs
FDA has accepted for priority review a Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps. Patients with the condition often experience recurrence despite previous treatment with surgery or systemic corticosteroids, the company says. The agency
Drugs
Genentech has submitted a supplemental NDA for Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. FDA is reviewing the application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process
Drugs
FDA has issued an updated draft guidance, Nonproprietary Naming of Biological Products, indicating that the agency no longer intends to modify the proper names of biological products that have already been licensed or approved under the Public Health Service Act without an FDA-designated suffix in their proper names. The
Drugs
FDA has accepted for review a Foamix Pharmaceuticals NDA for FMX101 (minocycline foam, 4%) for treating inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged nine years and older. The agency has set a user fee review action target of 10/20. The submission is supported