Drugs
Members of the FDA Pediatric Advisory Committee and Risk Management Advisory Committee will meet 9/26-27 to discuss the required pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets, as mandated by law. An FDA notice says the committees also will discuss pediatric data considerations for opioid
Drugs
Turner Scientific has petitioned FDA to approve and issue a proposed guidance drafted by Turner on nonclinical evaluation of ototoxicity during drug development. The petition says that Turner believes that current regulatory requirements “do not lead to adequate detection and prevention of harm to hearing and balance caused by medication
Devices
FDA has approved a Boston Scientific PMA supplement for its ImageReady MRI labeling for the Vercise Gevia Deep Brain Stimulation System to be used in a full-body magnetic resonance imaging (MRI) device. The device is designed to treat the symptoms of Parkinson’s Disease by delivering targeted electrical stimulation
Drugs
FDA has sent Dr. Reddy’s Laboratories an eight-observation Form FDA-483 — the third inspection form in six weeks for one of its facilities in India. The current inspection ended 8/20 at the firm’s Duvvada formulations manufacturing plant in Andhra Pradesh, according to the company. On 7/
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Deva Holding, Istanbul, Turkey (8/6): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to perform operations related
Drugs
FDA has issued Vanda Pharmaceuticals a complete response letter on a supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder. The letter said that “measures” contained in the NDA demonstrating improved sleep have “unclear clinical significance,” according to the company. Vanda previously reported that treated patients slept nearly three
FDA Policy/General
Federal Register notice: FDA has announced a 9/12 public workshop entitled “FDA Science Forum 2019.” The workshop shares with the public scientific research and collaborative efforts of FDA’s scientists and researchers. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts and 351(k) Biologics License Applications in Biosimilars User
Drugs
FDA has classified a recent inspection of Sun Pharmaceutical Industries’ troubled Halol, India plant as “no action indicated (NAI),” meaning the firm appears to have moved past GMP troubles that have been dogging it for years. According to FDA, a June inspection at the plant has been classified as NAI
Drugs
Genus Lifesciences has petitioned FDA seeking its rescission of a Lannett 505(b)(2) NDA for a cocaine hydrochloride product. Genus 12/2017 gained approval for Goprelto (cocaine hydrochloride) nasal solution, indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or
Devices
FDA has cleared an OrthoPediatrics 510(k) for its new PediFoot Deformity Correction System, which the company describes as the first pediatric-specific system to treat fractures and deformities of the foot and ankle. The device is intended for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small
Drugs
FDA has approved a Nabriva Therapeutics NDA for Xenleta (lefamulin) for treating adults with community-acquired bacterial pneumonia. Approval was based on data from two clinical trials in 1,289 patients where Xenleta was compared to the antibiotic moxifloxacin with or without linezolid. “The trials showed that patients treated with
FDA Policy/General
Panel to Discuss GSK NDA for OTC Nicotine Spray Federal Register notice: FDA announces a 9/18 panel meeting on a GlaxoSmithKline NDA for the over-the-counter marketing of nicotine oral spray for withdrawal symptoms. 08/16/2019 Nonclinical Osteoporosis Drug Study Guide Federal Register: FDA makes available a
FDA Policy/General
DEVICES Additive Orthopedics has received FDA 510(k) clearance for its 3D printed titanium digital fusion implant for use in fusion procedures. FDA has approved Advanced Accelerator Applications’ Netspot, the first kit for preparing gallium Ga 68 dotatate injection, a radioactive diagnostic agent for locating somatostatin receptor positive neuroendocrine tumors
FDA Policy/General
Nortech Systems has reached an agreement to acquire Devicix a medical product design and engineering firm. The company says the addition of Devicix will enhance and broaden Nortech’s capabilities for complete design, manufacturing and service, particularly for regulated medical devices. The Second Circuit Court of Appeals has affirmed a
Devices
FDA has approved Zimmer Biomet Spine’s The Tether – Vertebral Body Tethering System, the first spinal tether device intended to be used in children and adolescents to correct the most common form of scoliosis (idiopathic scoliosis) that has not responded to conservative treatment options, such as external bracing. It is
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for the guidance on “Dear Health Care Provider (DHCP) Letters: Improving Communication of Important Safety Information” (OMB Control Number 0910-0754). The document provides recommendations on the content and format of DHCP letters. During 2016-2018, FDA tracked
Drugs
FDA has approved AbbVie’s Rinvoq (upadacitinib), a 15 mg, once-daily oral Janus kinase inhibitor and follow-on therapy to its blockbuster rheumatoid arthritis (RA) drug Humira (adalimumab). Rinvoq is indicated for treating adults with moderately to severely active RA who have had an inadequate response or intolerance to
Devices
FDA has approved an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis (a narrowing of the heart’s aortic valve that restricts blood flow) who are at low risk for death or major complications associated with open-heart surgery to replace the damaged
FDA Policy/General
Federal Register notice: FDA has announced a 9/18 Nonprescription Drugs Advisory Committee meeting on a GlaxoSmithKline Consumer Healthcare NDA for the over-the-counter marketing of nicotine oral spray (1 mg). The proposed OTC use is to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking in adults
FDA Policy/General
Federal Register: FDA has made available a final guidance entitled “Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment.” The document provides recommendations on designing nonclinical bone quality studies to support the approval of drugs and biologics (e.g., recombinant proteins and monoclonal antibodies) for treating osteoporosis. To view the notice,