Drugs
FDA says it is requiring that a Boxed Warning be added to prescribing information and the Medication Guides for Lunesta (eszopiclone), Sonata (zaleplon), and Ambien, Ambien CR, Edular, Intermezzo, and Zolpimist (zolpidem) regarding rare but serious injuries that have happened involving sleepwalking, sleep driving, and engaging in other activities while
Drugs
The European Medicines Agency (EMA) says FDA has confirmed the capability of Bulgaria and Cyprus to carry out good manufacturing practice inspections at a level equivalent to the U.S. The two countries were included in the mutual recognition agreement between the European Union and the U.S. for inspections
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Newton Laboratories, Conyers, GA (4/23): FDA inspected the firm 3/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to thoroughly investigate any
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation” (OMB Control Number 0910-0456). The guideline was developed to identify general principles for preventing and controlling infectious diseases associated with xenotransplantation that may pose a risk
Drugs
FDA has accepted for priority review a Bayer NDA for darolutamide for treating non-metastatic castration-resistant prostate cancer (nmCRPC). The submission is based on data from the Phase 3 ARAMIS trial in men with nmCRPC. Darolutamide is an investigational, non-steroidal androgen receptor (AR) antagonist with what the company
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Administrative Detention and Banned Medical Devices — 21 CFR 800.55(g)(1), (g)(2), and (k), 895.21(d), and 895.229(a)” (OMB Control Number 0910-0114). The collection is related to the agency’s authority
Drugs
FDA has revamped its “Product-Specific Guidances for Generic Drug Development” Web page to add new functionality, including text searching for active ingredient or reference-listed drug/reference standard products, filtering search results, and easier navigation. The Web page now allows users to filter search results using a text search
Devices
FDA has cleared a CoapTech 510(k) for the PUMA-G System, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes. The device uses CoapTech’s point-of-care Ultrasound Magnet Aligned System platform to allow work in hollow body organs for novel diagnostic or interventional procedures, the company
Devices
Edwards Lifesciences has recalled its Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter due to difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment upon attempted retrieval. A recall notice says the company received reports of balloon fragmentation or detachment, which may cause damage
Devices
FDA has cleared a Biofourmis 510(k) for its RhythmAnalytics platform, a cloud-based software designed to automatically interpret cardiac arrhythmias. It uses an “enhanced deep-learning technique to detect over 15 types of cardiac arrhythmias along with beat-by-beat morphology computation which include ventricular arrhythmias, ventricular ectopic beats
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for Cabaret Biotech’s Yescarta (axicabtagene ciloleucel), a CD 19- directed genetically modified autologous T cell immunotherapy indicated for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The review
Drugs
Public Citizen has filed a lawsuit in DC federal court against FDA over a 2016 citizen petition that the agency has not acted on that sought a boxed warning on dopamine agonist medications, which can allegedly cause compulsive or uncontrollable behaviors. The petition sought labeling changes to six drugs that
FDA Policy/General
Guide on Bench Testing Data in Device Submissions Federal Register notice: FDA makes available a final guidance entitled “Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.” 04/26/2019 Guide on Polyethylene Used in Devices Federal Register notice: FDA makes available a final guidance
FDA Policy/General
BIOLOGICS FDA has approved Ipsen Biopharmaceuticals’ sBLA for Dysport (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. The company says Dysport is the first FDA-approved botulinum toxin for treating the condition. DEVICES FDA has cleared an EndoChoice Holdings
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.” The document describes relevant information that should be included in test report summaries, test protocols, and complete test reports for non-clinical bench performance testing
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices.” The document identifies the types of UHMWPE commonly in use in orthopedic implants, as well as the recommended information and testing that should be included in premarket submissions
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Device User Fee Small Business Qualification and Certification” (OMB Control Number 0910-0508). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Agreement for Shipment of Devices for Sterilization — 21 CFR 801.150” (OMB Control Number 0910-0131). The agreements allow manufacturers to ship misbranded products to be sterilized without initiating regulatory action and provides FDA with a
Drugs
FDA has approved CSL Behring’s four- and five-gram vial sizes for Zemaira [alpha1-proteinase inhibitor (human)], its therapy for treating Alpha 1 Antitrypsin Deficiency. Previously, Zemaira was available only in a one-gram vial, and the new sizes reduces the number of vials necessary for reconstitution, the company
FDA Policy/General
Federal Register notice: FDA makes available a final guidance on “Unique Device Identification: Convenience Kits.” The document discusses an agency exception for complying with unique device identification (UDI) system regulations that require that the label and device package of a device must bear a UDI. The exception is provided for
Drugs
FDA has announced a joint meeting 6/11-12 of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss safety concerns about safe prescribing and use of higher-range opioid doses. The agency is interested in learning more about how health
Devices
FDA has approved a Xvivo Perfusion PMA for the Xvivo Perfusion System with Steen Solution Perfusate, indicated to temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that are thought to be unacceptable for transplant. “The device allows the transplant team to perform a more careful assessment of lung