Devices
FDA has completed its review of the agency-required Medifocus post-approval study of its Prolieve Thermodilation system. The company says the study involved 225 symptomatic benign prostatic hyperplasia (BPH) patients. The 12-year study with five-year follow-up data confirms long-term safety, efficacy, and durability of the
Devices
FDA has cleared an EOS Imaging 510(k) for its hipEOS 3.0 surgical planning software. The surgical planning software for total hip arthroplasty is part of the company’s EOSapps suite of online 3D surgical planning solutions (spineEOS, hipEOS, kneeEOS). The hipEOS 3.0 is intended to simulate the
Devices
FDA has cleared a Royal Philips 510(k) for the Ingenia Elition 3.0T magnetic resonance (MR) device and two clinical applications, Philips Compressed SENSE and 3D APT. The device and apps provide faster exam times and improved analytics to allow automatic planning, scanning and exam processing, the company says.
Drugs
FDA commissioner Scott Gottlieb says the agency is taking steps to make the entire continuum of drug development more efficient as a way to lower costs and expand opportunities for innovation. Speaking 6/2 at the annual meeting of the American Society of Clinical Oncology, Gottlieb outlined steps being taken
FDA Policy/General
An FDA 5/23 Warning Letter to Creative Science Inc., Ballwin, MO, says the company’s P-Bloc product is a new animal drug that is not generally recognized among experts as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. Further, the letter
Devices
FDA has cleared a Spineology 510(k) for its Rampart One Standard ALIF interbody fusion system for use with or without supplemental fixation. The system includes both standard and oblique interbody devices, each with integrated fixation screws. The device is designed to minimize vascular retraction and exposure, the company says.
Drugs
FDA has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Amgen’s Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with
FDA Policy/General
Federal Register notice: FDA has issued a proposed order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection from postamendments Class 3 (premarket approval) devices into Class 2 (special controls), subject to premarket notification. The devices are intended
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.” The document focuses on appropriate criteria for inclusion in adult trials at various stages of drug development, considerations for dosing and pharmacokinetic evaluations, safety monitoring, and ethical
Drugs
CDER director Janet Woodcock has proposed changes to her Center’s new drug regulatory program that are intended to free up resources so staff can “focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly,
Drugs
FDA has made available a guidance on “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” The document provides recommendations on formal meetings between the agency and sponsors or applicants relating to developing and the review of biosimilar or interchangeable biological products. Formal meetings under the guidance
Drugs
Hospira has recalled two lots of naloxone hydrochloride injection, 0.4 mg/mL, 1 mL in 2.5 mL in its Carpuject single-use cartridge syringe system due to the potential presence of embedded and loose particulate matter on the syringe plunger. “In the event that impacted product is administered
Devices
FDA is alerting health care providers about five additional deaths associated with the use of liquid-filled intragastric balloon devices for obesity treatment (see earlier story). “We have been carefully tracking adverse events, including a total of 12 deaths over the past two years, that have been reported in patients
Devices
FDA has cleared a Micronics 510(k) for its PanNAT STEC Test and its use in detecting Shiga toxin-producing E. coli. The test is performed in a disposable microfluidics-enabled cartridge and is a qualitative, in vitro nucleic acid amplification-based assay that simultaneously detects and differentiates the stx1
FDA Policy/General
Amneal has acquired Gemini Laboratories, a company focused on branded pharmaceuticals, for $117 million. Gemini’s lead product is Unithroid to treat hypothyroidism. Amneal also entered into a licensing agreement for the U.S. market with Spanish company MabXience SL for its biosimilar candidate for Roche’s Avastin (bevacizumab). Surmodics
FDA Policy/General
Guide on How to Develop REMS Shared System Federal Register notice: FDA makes available a draft guidance entitled “Development of a Shared System REMS.” 06/01/2018 ICH Guide on Q12 Post-approval Drug Changes Federal Register notice: FDA makes available a guidance entitled “Q12 Technical and Regulatory Considerations for
Devices
FDA has cleared a Medicrea Group 510(k) for patient-specific spinal cages through the extension of its UNiD ASI (Adaptive Spine Intelligence) technology to select from its IB3D range of 3D-printed titanium interbody devices. The clearance allows Medicrea to digitally plan, manufacture in-house and supply a 3D-
Drugs
FDA has approved an Eli Lilly and Incyte NDA for Olumiant (baricitinib 2mg), a once-daily oral drug for treating adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies. Approval is based on data from
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Development of a Shared System REMS.” The document provides recommendations on developing a risk evaluation and mitigation strategy shared system for multiple prescription drug (including biological) products. It also describes some of the possible benefits of a shared system,
Drugs
Federal Register notice: FDA is making available a draft guidance entitled “Waivers of the Single, Shared System REMS Requirement.” The document describes how FDA intends to consider granting a waiver on the requirement that an ANDA applicant and reference-listed drug maker use a single, shared system for a required
Drugs
Apotex has recalled one lot of fluticasone propionate nasal spray (50 mcg per spray) due to the potential for the product to contain small glass particles. The glass particles could block the actuator and impact pump functionality, a recall notice says. “Local trauma to the nasal mucosa might occur with
FDA Policy/General
FDA has approved an Aratana Therapeutics supplemental New Animal Drug Application for Nocita (bupivacaine liposome injectable suspension) to include its use in cats as a peripheral nerve block to provide regional post-operative analgesia following onychectomy. The Animal Drug User Fee Act review date is set for 7/30. Nocita