Devices
FDA says it cleared 2/25 a new version of the LivaNova heater-cooler system 3T that has changes to help reduce the risk of patient infections, including updated labeling with validated cleaning and disinfection instruction and the 3T aerosol collection set. Announcement of the clearance was included in an
Devices
Tytek Medical has recalled its PneumoDart-Pneumothorax Needle due to the risk of blocked needles, which is caused by the presence of adhesive from the assembly process. “If the needle is blocked, emergency treatment is delayed which can lead to heart or lung failure, or death,” a recall notice says.
Devices
FDA has issued two final guidances to help device makers that seek Clinical Laboratory Improvement Amendments (CLIA) waivers for certain products. The first guidance, Recommendations for Dual 510(k) and CLIA Waiver by Application Studies, is intended to assist manufacturers in using the agency’s dual 510(k) and CLIA
Drugs
FDA has approved Eli Lilly’s Trulicity (dulaglutide) for reducing major adverse cardiovascular events (MACE) in adults with Type 2 diabetes who have established cardiovascular (CV) disease or multiple CV factors. The company says Trulicity is the only Type 2 diabetes drug approved to reduce the risk of MACE for
Drugs
As part of its efforts to deal with impacts from the global spread of the coronavirus, FDA has identified about 150 prescription drugs (antibiotics, generics and some brand drugs) that could be in short supply if plants in China that make the active pharmaceutical ingredients are restricted from manufacturing or
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Revision 7).” The document identifies certain submission types that warrant an exemption or a long-term waiver from the requirement to
FDA Policy/General
Federal Register notice: FDA is seeking comments on a draft Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Module 1 Implementation Package. The conformance guide provides specifications, recommendations, and general considerations on how to submit eCTD v4.0-based electronic submissions using
FDA Policy/General
Federal Register notice: FDA has announced a 5/15 Allergenic Products Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on the safety and efficacy of DBV Technologies’ Peanut (Arachis hypogaea) Allergen Extract for treating patients aged four to 11 years old with a confirmed diagnosis of
Drugs
In a new post on FDA’s Web site, two senior CDER officials discuss how real world data (RWD) and real world evidence (RWE) can be used in making regulatory decisions. “RWD, according to the FDA’s definition, are data that are routinely collected about a patient's health
Drugs
Taro Pharmaceuticals has recalled two lots of phenytoin oral suspension USP, 125 mg/5 mL in 237 mL bottles because it may not re-suspend when shaken, which could result in under- or over-dosing, according to a recall notice. Phenytoin is indicated for treating tonic-clonic (grand mal) and
Devices
FDA has granted de novo marketing authorization to Asuragen’s AmplideX Fragile X Dx and Carrier Screen Kit for detecting a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual disability. The test is intended as an aid in diagnosing
Drugs
FDA has accepted for review a GlaxoSmithKline supplemental NDA for Zejula (niraparib) as a first-line maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. The submission is supported by data from the Phase 3 PRIMA study, which the company says
Devices
FDA has cleared an Avanos Medical 510(k) for its new, 80-Watt Coolief Radiofrequency (RF) system for pain-reducing neurological lesion procedures. The device includes an RF generator, peristaltic pump and therapy cables that allows physicians to perform cooled, standard, pulsed, transdiscal and dual bipolar RF procedures, the company
Drugs
FDA has approved a Teva Respiratory supplemental NDA for ArmonAir Digihaler (fluticasone propionate) Inhalation Powder, an inhaled corticosteroid delivered by Teva’s Digihaler device for asthma maintenance treatment. The inhaler contains built-in sensors and connects to a companion mobile application that provides information on inhaler use to people with
FDA Policy/General
Info Collection for Device Corrections/Removals Federal Register notice: FDA seeks comments on an information collection extension for “Medical Devices; Reports of Corrections and Removals — 21 CFR Part 806” (OMB Control Number 0910-0359). 02/21/2020 Final Rule Defines ‘Biological Product’ Federal Register final rule: FDA issues a final
FDA Policy/General
DEVICES FDA has approved a Medtronic PMA for its Melody Transcatheter Pulmonary Valve (TPV) and its implanted use in patients whose surgical bioprosthetic pulmonary heart valves have failed. The device is designed specifically for the pulmonic position. It is placed inside a failing pulmonic surgical heart valve through the recently
FDA Policy/General
QT Vascular has submitted an investigational device exemption to FDA to begin the pivotal study of Chocolate Touch, its drug-coated balloon, in the U.S. The company says the balloon has a unique nitinol constraining structure that cause it to open in a controlled uniform fashion compared to conventional
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Devices; Reports of Corrections and Removals — 21 CFR Part 806” (OMB Control Number 0910-0359). The agency’s regulations require that within 10 working days of initiating any action to correct or remove a device to
FDA Policy/General
Federal Register final rule: FDA has issued a final rule to amend its regulation that defines “biological product” to incorporate changes made by legislation, and to provide the interpretation of the statutory term “protein.”’ Under the rule, the term protein is defined as any alpha amino acid polymer with a
FDA Policy/General
Federal Register proposed order. FDA is proposing to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid diagnostic and supplemental tests, Class 3 devices with the product code MZF, into Class 2 (special controls), subject to premarket notification. FDA’s decision to reclassify the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Annual Reporting for Custom Device Exemption” (OMB Control Number 0910-0767). Agency regulations require custom device makers to submit information in a custom device annual report. To view the notice, click here.
Drugs
FDA has launched a new resource for external and agency researchers collecting historical information about FDA’s drug approvals. The compilation of new molecular entity drug and new biologic approvals is provided in a .CSV file that goes back to 1985. The agency says that it will continue to provide