Devices
A new safety alert warns against an increased risk of corneal haze associated with Optics Medical’s Raindrop Near Vision Inlay. The inlay is a transparent, curved hydrogel disc smaller than the eye of a needle. It was designed to be surgically implanted into the cornea to improve near vision
Drugs
FDA has extended by three months its review of a Bristol-Myers Squibb 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
FDA Policy/General
Federal Register notice: FDA has canceled an 11/7 Allergenic Products Advisory Committee meeting that was scheduled to discuss the use of challenge studies in allergenic product clinical development for products intended to diagnose and treat allergies caused by aeroallergens. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a publication containing modifications to the list of standards it recognizes for use in premarket reviews (FDA Recognized Consensus Standards). The publication, “Modifications to the List of Recognized Standards, Recognition List Number: 050” is intended to assist manufacturers who elect to declare conformity
FDA Policy/General
Federal Register notice: FDA has withdrawn the approval of 20 NDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for MedImmune’s Imfinzi (durvalumab), indicated for treating patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of
FDA Policy/General
Former FDA Associate Chief Counsel for Enforcement Beth Weinman has joined Ropes & Gray at its Washington, D.C. office as counsel in the firm’s life sciences and FDA regulatory practice. At FDA, she advised Office of Criminal Investigations agents investigating potential criminal violations and worked with the U.
Devices
FDA has announced a voluntary Optical Coherence Tomography (OCT) Premarket Notification (510(k)) Pilot Program, which is intended to develop and refine individual premarket testing recommendations for OCT devices through the pre-submission process to yield more consistent premarket submissions and improve review process predictability. “We are planning to achieve
Devices
FDA has cleared a Levita Magnetics 510(k) for an expanded indication to market the company’s Levita Magnetic Surgical System for use in bariatric procedures. Previously, the device was indicated for use in gallbladder removal procedures. It is designed to grasp and retract the body and the fundus of
Drugs
FDA has approved Regeneron’s Dupixent (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Dupixent works by inhibiting the overactive signaling of interleukin-4 and interleukin-13, two key
FDA Policy/General
Quantitative Efficacy/Risk Info in DTC Ads Federal Register notice: FDA makes available a draft guidance entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.” 10/19/2018 Regulatory Review Period for SK Chemicals’ Afstyla Federal Register notice: FDA determines for patent extension-related
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.” The document describes how to include drug quantitative efficacy or risk information in DTC promotional materials, and to make the language and presentation more consumer-
Devices
FDA has updated a safety communication to reduce potential cardiac surgery infection risks associated with the LivaNova 3T Heater-Cooler Systems. The update follows a 10/18 medical device correction letter from LivaNova to inform customers of actions to take to reduce potential infections. The device is intended to provide
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for SK Chemicals’ Afstyla (antihemophilic factor (recombinant), single chain), indicated for use in children and adults with hemophilia A (congenital Factor VIII deficiency). The regulatory review period is 1,734 days, including 1,371 days
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Regeneron Pharmaceuticals’ Dupixent (dupilumab), indicated for treating adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The review
FDA Policy/General
Federal Register notices: FDA has made available the following six medical device classification orders: * Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery System (PDF) * General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device (PDF) * General and Plastic Surgery Devices; Classification of the Light Based Energy Source
Devices
FDA has approved Abbott’s HeartMate 3 Left Ventricular Assist Device (LVAD) as a destination therapy for people living with advanced heart failure. The device uses the company’s Full MagLev (fully magnetically-levitated) Flow, which reduces trauma to the blood passing through the pump while improving flow, the company
Devices
FDA has issued Ocular Therapeutix a 10/17 Warning Letter over the company’s compliance with data collection and information reporting obligations in a post-approval device exposure registry study required as a condition for PMA approval for ReSure Sealant. The company says it is required to provide periodic reports
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Genentech’s Ocrevus (ocrelizumab), indicated for treating patients with relapsing or primary progressive forms of multiple sclerosis. The regulatory review period is 4,844 days, including 4,509 days that occurred during the testing
Drugs
Experts have varying opinions on the legality and potential effectiveness of a Trump administration proposal to lower drug prices by requiring manufacturers to include pricing information in television ads. That’s the conclusion drawn from a Bloomberg Law online post. Under the proposal announced 10/15, the HHS Centers for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” The document is intended to help sponsors protect against risks, such as ransomware campaigns, that could disrupt clinical operations and delay patient care. To view the notice, click
Devices
A 10/10 CDRH Webinar explained the Quality in 510(k) (Quik) Review Program that provides an alternate method to submit a 510(k) to FDA using the eSubmitter software to format the submission. CDRH biomedical engineer Angela DeMarco said the purpose of the Quik pilot program is to simplify