FDA Policy/General
Federal Register notice: FDA has announced a 6/6 Antimicrobial Drugs Advisory Committee meeting to discuss a Global Alliance for TB Drug Development NDA for pretomanid tablets for oral administration. The submission seeks a proposed indication as part of a combination regimen with bedaquiline and linezolid in adults for treating
Drugs
FDA says it has continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine, urging consumers on the importance of timely immunizations. “It deeply concerns us when we see preventable diseases such as measles or mumps reemerging in the United States and threatening our communities,
Devices
FDA has granted a de novo clearance to NeuroSigma for its prescription-only Monarch external Trigeminal Nerve Stimulation (eTNS) System, the first medical device to treat attention deficit hyperactivity disorder (ADHD). The device is indicated for patients aged seven to12 years old who are not currently taking prescription ADHD medications.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Deeming Tobacco Products To Be Subject to the FD&C Act” (OMB Control Number 0910-0768). The collection is related to premarket tobacco applications that require full reports of all investigations of health risks; a full
Drugs
FDA has approved a Merck supplemental NDA for use of its Keytruda (pembrolizumab) plus axitinib (Pfizer’s Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma. Approval was based on data from the KEYNOTE‑426 (NCT02853331), an 861-patient trial in those who had not received
FDA Policy/General
Federal Register notice: FDA has announced a 6/19 meeting of its Circulatory System Devices Panel of the Medical Devices Advisory Committee. Panel members are scheduled to discuss and make recommendations on information related to recent observations of increased long-term mortality in peripheral arterial disease patients treated with paclitaxel-
Drugs
Alvogen has recalled two lots of fentanyl transdermal system 12 mcg/h transdermal patches due to a labeling error. “A small number of cartons labeled 12 mcg/h fentanyl transdermal system patches contained 50 mcg/h patches,” a recall notice says. “The 50 mcg/h patches that were included in
Drugs
FDA has announced that the National Academies of Science, Engineering, and Medicine (NASEM) is conducting a study to examine the clinical utility of treating patients with compounded “bioidentical hormone therapy” products, such as progesterone and testosterone. NASEM is expected to provide a report evaluating the available scientific evidence relating to
Drugs
FDA has accepted a Molecular Templates IND application for MT-5111, an engineered toxin body (ETB) targeting HER2-positive solid tumors. The company expects to start dosing in a Phase 1 study in relapsed/refractory patients with HER2-positive solid tumors in the third quarter. Molecular Templates describes MT-5111
FDA Policy/General
Assessment of Quantitative Imaging Devices Guide Federal Register notice: FDA makes available a draft guidance entitled “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.” 04/19/2019 Draft Guide on Nitinol-Containing Medical Devices Federal Register notice: FDA announces the availability of a draft guidance entitled “Technical Considerations
FDA Policy/General
DEVICES FDA has cleared a Bausch & Lomb 510(k) for its frequent replacement silicone hydrogel contact lenses made with MoistureSeal Technology. Medtronic has received FDA PMA approval for its MiniMed 530G with Enlite, an artificial pancreas system with Threshold Suspend automation for people with diabetes 16 and older. The
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.” The document says that manufacturers preparing premarket submissions for devices that include quantitative imaging functions should provide performance specifications for the quantitative imaging functions, supporting performance data to demonstrate
FDA Policy/General
Federal Register notice: FDA has announced the availability of a draft guidance entitled “Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol.” The document is intended to provide clarity and consistency in recommended non-clinical assessments across a variety of medical devices that contain nitinol. To view the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Bispecific Antibody Development Programs.” The document covers general considerations and recommendations for these programs, as well as regulatory, quality, nonclinical, and clinical considerations in the context of bispecific antibody development programs. It does not discuss development considerations for other
Drugs
FDA has approved a Teva Pharmaceuticals ANDA for the first generic naloxone hydrochloride nasal spray (Adapt Pharma’s Narcan), indicated for stopping or reversing the effects of an opioid overdose. In announcing the approval, FDA also said it is “planning new steps to prioritize the review of additional generic drug
Drugs
Pfizer and Eli Lilly have reported safety concerns with a Phase 3 study comparing tanezumab 2.5 mg and 5 mg with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with moderate-to-severe osteoarthritis (OA) of the hip or knee. The study, which was designed to evaluate tanezumab’s long-
Drugs
FDA has given approval for MediciNova to proceed with a Phase 2b/3 clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) patients. If the pivotal trial is successful, data will be used to support a future NDA, according to the company. FDA concurred, it says, on the
Drugs
FDA has approved an Akorn ANDA for a generic copy of Bausch & Lomb’s Lotemax (loteprednol etabonate) ophthalmic suspension, 0.5%, indicated for treating post-operative inflammation following ocular surgery and the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of
Devices
FDA has cleared a Medicrea Group 510(k) for expanded use of its proprietary surgical planning software, UNiD Hub, to integrate a complete database of the company’s implant portfolio to directly simulate and select implants during planning for surgery. “The integration of an implant database with Medicrea’s UNiD
FDA Policy/General
Federal Register notice: FDA has extended the comment period for a 2/26 proposed rule on the regulation of over-the-counter sunscreen monograph products. Comments can now be submitted until 6/27. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has corrected a 2/26 proposed rule on the regulation of over-the-counter sunscreen monograph products. The document was published with formulas that were illegible, and corrections were made to improve its accuracy. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Abbreviated New Animal Drug Applications — Sections 512(b)(2) and (n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and (n)(1))” (OMB Control Number 0910-0669). To view