FDA Policy/General
DEVICES FDA has approved a Medtronic PMA supplement for a new arm indication for the Guardian Sensor 3 glucose monitor that will enable patients to wear the sensor on the upper arm. The company says this is the only sensor FDA approved to control automated insulin delivery via a hybrid
Devices
Centerline Biomedical has submitted a 510(k) for its Intra-Operative Positioning System (IOPS), a non-radiation-based surgical navigation system. The device is intended to leverage anatomical mapping and modeling algorithms and electromagnetic tracking technology to provide three-dimensional color visualization and real time guidance during endovascular procedures, the
Devices
Draeger Medical has recalled (Class 1) its VentStar and ID Breathing Circuits and Anesthesia Sets manufactured 1/2016 to 11/2018 due to incorrect assembly concerns. The single-use, disposable, accessory devices are used with a ventilator or anesthesia machine to provide mechanical ventilation and critical breathing support to infant,
Drugs
An updated FDA drug safety alert about the safety of some generic versions of angiotensin II receptor blocker (ARB) medicines that contain nitrosamine impurities (N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)), which are probable human carcinogens, has now dismissed significant safety concerns. “We were deeply concerned when we learned about
Devices
FDA has cleared a Zimmer Biomet Holdings 510(k) for the Rosa Knee System for robotically-assisted total knee replacement surgeries. The device, according to the company, features 3D pre-operative planning tools and “real-time, intraoperative data on soft-tissue and bone anatomy designed to improve bone cut accuracy
Drugs
FDA says that after the partial government shutdown ends it will extend or reopen the comment period on an 11/20/2018 Federal Register notice entitled “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments” (Docket No. FDA-2018-N-3017). In the notice, FDA is
Drugs
FDA has lifted a partial clinical hold against MacroGenics and its Phase 1 monotherapy and combination studies of cancer drug MGD009, a B7-H3 CD3 bispecific DART molecule. New patient enrollment has been cleared to proceed with the trials, the company says. The hold was placed 12/7/2018 following
Drugs
Furloughed FDA employees are expected to return to work early next week under a 1/25 tentative agreement reached between President Trump and Congress to re-open the government for three weeks while negotiations continue on border security issues. A short term budget resolution gives FDA some breathing room, according
Devices
FDA has approved a CorMatrix Cardiovascular early feasibility study IDE to evaluate the safety and feasibility of the Cor Tricuspid ECM cardiac valve for adults with endocarditis and for pediatric patients with congenital heart valve disease. The device is described by the company as the first cardiac valve of its
Drugs
FDA has issued two draft guidances to help improve the agency’s ability to ensure that risk mitigation programs that are put in place for certain drugs and biologics as a requirement of their approval are working. The first guidance, REMS Assessment: Planning and Reporting, describes how to develop a
Drugs
Based on recent discussions with FDA, Bristol-Myers Squibb has withdrawn a supplemental BLA for an indication in metastatic first-line non-small cell lung cancer for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) in patients with tumor mutational burden (TMB) greater or equal to 10 mutations/megabase. The agency
Devices
FDA has cleared a Hologic de novo submission for the Aptima Mycoplasma genitalium Assay, a new test to aid in the diagnosis of the sexually-transmitted infection called Mycoplasma genitalium (M. gen.). This is the first test authorized by the agency to test for this bacterium, which is associated with
Devices
King & Spalding attorneys have posted a detailed review of three documents released by FDA 1/7 relating to the agency’s software precertification pilot program. The documents are: (1) the Developing a Software Precertification Program: A Working Model (Version 1.0); (2) the Software Precertification Program: 2019 Test Plan;
Drugs
The chairman of the FDA Anesthetic and Analgesic Drugs Advisory Committee, anesthesiologist Raeford Brown, says the agency is putting the interests of narcotic drug manufacturers ahead of public health. In an explosive interview with The Guardian, Brown took particular aim at the recent FDA approval of AcelRx’ Dsuvia (sufentanil sublingual
Drugs
FDA has approved an Amerigen Pharmaceuticals ANDA for a generic version of Shire’s Adderall XR (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, extended-release capsules) 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg. Amerigen is currently selling an “authorized generic” version
Drugs
FDA has approved Sanofi Pasteur’s 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) to include children age 6 through 35 months. Approval is supported by clinical data from a Phase IV safety and immunogenicity study conducted in nearly 2,000 children, which demonstrated that one or two doses
Drugs
FDA has placed a partial clinical hold on Advaxis’ Phase 3 AIM2CERV trial of axalimogene filolisbac (AXAL) in high-risk, locally advanced cervical cancer. The company says the hold is related to FDA requests for additional information on certain AXAL chemistry, manufacturing, and controls matters. The agency did not cite
Drugs
FDA has approved a Teligent ANDA for a generic copy of Fougera Pharmaceuticals’ Temovate (clobetasol propionate ointment USP) 0.05%. The topical steroid is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis. Annual sales of clobetasol propionate
Devices
AdvaMed says it is proposing legislation to help “fix” some of the disruption FDA is experiencing in collecting user fees and reviewing medical device applications during this and any future government shutdowns. Under the proposal, the trade group says, FDA could continue to collect user fees and review applications that
Drugs
The Supreme Court unanimously refused to reinstate Helsinn Healthcare’s patent for its anti-nausea drug Aloxi, thereby supporting Teva, which launched a generic version of the drug last year. Reuters reports that Aloxi is indicated to prevent nausea and vomiting in patients receiving chemotherapy. According to the report, the
Devices
Attorneys general in 46 states have reached a $120 million settlement with Johnson & Johnson and DePuy to resolve allegations that the medical device company unlawfully promoted two metal-on-metal hip implant devices—the ASR XL and the Pinnacle Ultamet. An announcement by New York State attorney general Letitia
Devices
FDA has cleared a Perspectum Diagnostics 510(k) for MRCP+ biliary visualization software. The artificial intelligence (AI) device is designed to enable quantitative and objective assessment of the bile ducts. The company says it uses quantitative MRI and AI algorithms for magnetic resonance cholangiopancreatography (MRCP) images “to provide improved visualization