Devices
As a follow-up to a 12/2018 safety communication on preliminary findings from studies on marketed duodenoscopes, a new update says the findings now show that up to 5.4% of all properly collected samples tested positive for “high concern” organisms, which is significantly higher than the earlier 3%
Drugs
FDA has granted Janssen Pharmaceutical an accelerated approval for Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. Patients should be
Devices
FDA says it is helping to mitigate a temporary shortage of pediatric breathing tubes due to the recent closure of Sterigenics’s Willowbrook, IL sterilization facility. Last month, the agency was notified by health care providers, patients, and Smiths Medical that the facility’s closure caused a potential device shortage
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for Shionogi’s Symproic (naldemedine tosylate) for treating opioid-induced constipation in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid
FDA Policy/General
Federal Register notice: Based on a de novo request, FDA has classified Timpel’s Enlight 1810 ventilatory electrical impedance tomograph into Class 2 (special controls). The agency describes the device as a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-
Devices
The Protect Medical Innovation Act of 2019 (H.R. 2207), which is sponsored by both Democrats and Republicans, would permanently repeal the medical device excise tax. AdvaMed CEO Scott Whitaker praised the legislation, saying the medical technology industry “is facing a $20 billion tax increase at year-end, when the
Devices
FDA has cleared an Elucent Medical 510(k) for the EnVisio Surgical Navigation System. “Placed at the time of the breast biopsy, Elucent Medical’s permanently implantable wireless SmartClip Soft Tissue Marker provides an alternative to painful and costly localization procedures, in which the standard approach is to place a
Drugs
Takara Bio has submitted a Drug Master File to FDA for the liquid formulation of RetroNectin GMP grade. The reagent is often used during the manufacturing of CAR T-cell therapies. “In the manufacturing of such therapies, a patient’s T cells — responsible for immune homeostasis — are extracted, modified to
Devices
FDA has cleared an Ortho Clinical Diagnostics 510(k) for the Vitros XT MicroSlides, featuring new multi-test technology that allows labs to run two tests simultaneously on one slide. The product pairs tests that physicians typically order together, including triglycerides and cholesterol, urea and creatinine, and glucose and calcium.
Drugs
Following its review of postmarketing studies, FDA is ordering Sprout Pharmaceuticals to make safety labeling changes for its Addyi (flibanserin) that is indicated to treat acquired, generalized hypoactive sexual desire disorder in postmenopausal women. An agency media statement says that at the time Addyi was approved 8/2015, FDA reviewed
Devices
FDA is extending the comment period by 30 days for its Modernizing the Food and Drug Administration's 510(k) Program: Request for Comments regarding FDA’s proposal to consider making public on its Web site cleared devices that demonstrated substantial equivalence to older predicate devices. Late last year,
FDA Policy/General
Federal Register final rule: FDA has established that certain active ingredients are not allowed to be used in OTC hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water. Drug products containing these ineligible active ingredients will require approval under an NDA or
Devices
FDA has issued its finalized list of medical device accessories suitable for Class 1. A Federal Register notice says the agency has determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for the accessories. It says the determination was made based on the risks
Devices
FDA has cleared a CivCo Radiotherapy 510(k) for its GrayDuck Stents, which are intended to provide custom oral positioning with repeatable tongue deviation during radiotherapy. The device is designed to improve patient treatment and outcomes by sparing the tongue, taste buds and salivary glands from unnecessary doses, the company
Drugs
The Combination Products Coalition says it would like FDA to confirm that the scope of the agency’s draft guidance on recognition of voluntary consensus standards related to pharmaceutical quality includes combination products under CDER jurisdiction. In its comment letter, the coalition also asks FDA to clarify (1) how the
Drugs
Immuron says it is planning to develop and seek FDA approval for IMM-124E, its bovine polyclonal antibody drug candidate for preventing travelers’ diarrhea (TD). The product under the brand Travelan is approved for this indication in Australia, and it is marketed in the U.S. and Canada as a
Drugs
A Florida federal court has denied the latest motion filed by Apotex to dismiss Amgen’s complaint in a follow-on suit about Apotex’ pegfilgrastim and filgrastim biosimilar candidates. The two companies have been involved in multiple patent lawsuits over the two biosimilars since 2015. A Big Molecule Watch online
Drugs
Takara Bio has submitted a Drug Master File to FDA for the liquid formulation of RetroNectin GMP grade. The reagent is often used during the manufacturing of CAR T-cell therapies. “In the manufacturing of such therapies, a patient’s T cells — responsible for immune homeostasis — are extracted, modified to
Devices
FDA has cleared an Elucent Medical 510(k) for the EnVisio Surgical Navigation System. “Placed at the time of the breast biopsy, Elucent Medical’s permanently implantable wireless SmartClip Soft Tissue Marker provides an alternative to painful and costly localization procedures, in which the standard approach is to place a
FDA Policy/General
Senate Finance Committee chairman Charles Grassley (R-IA) is asking HHS secretary Alex Azar for information on the department’s efforts to implement recommendations from the HHS Inspector General (OIG) to improve cybersecurity in eight HHS agencies including FDA. In a 4/9 letter, Grassley says the OIG recommendations included
Drugs
As part of FDA’s role in combatting the opioid crisis, CDER has developed a Public Health Assessment via Structural Evaluation (PHASE) methodology to provide a structure-based evaluation of a newly-identified opioid’s risk to public safety. Writing online in Clinical Pharmacology and Therapeutics, seven CDER staffers say
Devices
FDA has cleared a Getinge 510(k) for a new software version for the Servo-u and Servo-n mechanical ventilator platform. The software release includes the addition of Servo Compass and High Flow therapy as well as additional advancements for ventilation therapy support, according to the company. The software