Drugs
FDA has cleared a Masimo 510(k) for the measurement of respiration rate from the pleth (RRp) on the MightySat Rx spot-check fingertip pulse oximeter, as well as its indication for use in the home environment. The MightySat Rx also measures functional oxygen saturation, pulse rate, perfusion index, and
Devices
FDA has approved an expanded use for AbbVie’s Imbruvica (ibrutinib) — combination use with Gazyva (obinutuzumab) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The latest approval expands Imbruvica’s use as a single agent or in combination with bendamustine and rituximab for adult
Devices
CDRH approved a record 106 novel devices last year, eclipsing the 40-year record it set in 2017 when 99 such devices were approved. The agency also granted 112 breakthrough device designation requests since the start of the program in 4/2015, and in 2018 it approved or cleared nine
Drugs
A “welcome back” email from CDER director Janet Woodcock to Center employees returning to work from the just-ended partial government shutdown instructs employees to “pick up the pieces and prioritize the work that has piled up. We can expect other parts of the agency and government to be doing
Drugs
FDA has approved an I-Mab Biopharma IND for TJC4, a human anti-CD47 monoclonal antibody for cancer immunotherapy. TJC4 is the third candidate from I-Mab’s proprietary discovery pipeline to be approved for clinical trials by the agency. Unlike other known CD47 antibodies under development, TJC4 works by
Drugs
FDA has approved a Promius Pharma NDA for Tosymra (sumatriptan nasal spray) 10 mg, indicated for the acute treatment of migraine with or without aura in adults. The company says the nasal spray is formulated using a proprietary novel excipient known as Intravail “to achieve blood levels similar to a
Devices
FDA has announced a 3/25-26 General and Plastic Surgery Devices Panel meeting to discuss topics concerning the benefit-risk profile of breast implants. The agency plans to publish a Federal Register notice and agenda on its Advisory Committee Calendar Web page 15 days in advance of the meeting.
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