Biologics
FDA has accepted a Novartis BLA for brolucizumab (RTH258) for treating wet age-related macular degeneration (AMD), also known as neovascular AMD. The company used a six-month priority review voucher to expedite FDA’s review. The submission is based on Phase 3 data from the HAWK and HARRIER trials.
FDA Policy/General
Regulatory Review Period for Shionogi’s Symproic Federal Register notice: FDA determines the regulatory review period for Shionogi’s Symproic (naldemedine tosylate) for treating opioid-induced constipation in adult patients with chronic non-cancer pain. 04/12/2019 Class 2 for Ventilatory Electrical Impedance Tomograph Federal Register notice: Based on
FDA Policy/General
BIOLOGICS Baxter International has received FDA approval for Flexbumin [Albumin (Human)] USP 5% Solution. indicated for hypovolemia hypoalbuminemia due to general causes burns and in patients undergoing cardiopulmonary bypass surgery. DEVICES FDA has cleared ElMindA Ltd’s BNA Analysis System for assessing brain function in 14 to 24 year-olds.
Drugs
FDA has approved an expanded label for Merck’s Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with Stage 3 non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors
FDA Policy/General
Federal Register notice: FDA has classified suitable medical device accessories into Class I as required by the FDA Reauthorization Act of 2017. The agency determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for the accessories. It made the determinations based on the risks
Drugs
Former Pharmakon Pharmaceuticals CEO Paul J. Elmer has been convicted of conspiracy to defraud FDA and nine counts of adulterating drugs at the company’s Noblesville, IN drug compounding facility. The government charged that from 2013 to 2016, Elmer and Caprice R. Bearden, Pharmakon’s former compliance director, caused Pharmakon
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