Devices
FDA has granted breakthrough device designation to the Novocure Novo TTF-200T system, a tumor treating fields (TTFields) delivery system intended for use with Genentech’s Tecentriq (atezolizumab) and Avastin (bevacizumab) for the first-line treatment of patients with unresectable or metastatic liver cancer. The company says the designation was
Drugs
FDA and the Federal Trade Commission have issued Warning Letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent diabetes. An FDA statement (contains links to the letters) says the letters were issued to: Live Good Inc.; Pharmagenics LLC; Lysulin Inc.: Nuturna International
Drugs
Responding to an FDA objection to a new dietary ingredient notification submitted by Charlotte’s Web to demonstrate that its full-spectrum hemp extract is reasonably expected to be safe, Council for Responsible Nutrition CEO Steve Mister says Congress must step in and regulate the CBD (cannabidiol) marketplace. Mister appeared
Drugs
ICU Medical has recalled one lot (2,112 units) of Aminosyn II, 15% (amino acid injection) sulfite-free intravenous solution due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with other particles. The company says it became aware of the issue while inspecting
Drugs
Moderna says that “robust antibody responses” have been observed in a Phase 2 study of a third dose/booster of its mRNA-1273 Covid vaccine. In a portfolio update, the company also says it completed the rolling submission process for a BLA for the Covid vaccine. In development, it says,
Drugs
FDA has accepted for review a Myovant Sciences and Pfizer supplemental NDA for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing moderate to severe pain associated with endometriosis. The agency set a user fee review action target date of 5/6/2022. The
Drugs
Apellis Pharmaceuticals says it plans to file an NDA in the first half of 2022 after reporting top-line results from the Phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplan, an investigational targeted C3 therapy, in 1,258 adults with geographic atrophy secondary to age-related macular degeneration. Geographic
FDA Policy/General
Federal Register notice: FDA is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee. Nomination should be submitted by 11/8. To view the notice, click here.
FDA Policy/General
Federal Register notice: CDER is announcing its Novel Excipient Review Pilot Program. The voluntary pilot would allow excipient manufacturers to gain FDA review of certain novel excipients prior to their use in drug formulations. It is intended to foster excipient development that may be useful in scenarios in which excipient
Drugs
Wilmington, MA-based Azurity Pharmaceuticals has recalled one lot of Firvanq (vancomycin hydrochloride for oral solution) 50 mg/mL kit because some products in the affected lot have been found to incorrectly contain an omeprazole diluent instead of the Firvanq diluent. The vancomycin may not be completely solubilized if the
Drugs
CDER researchers say their review of patient-reported outcomes (PROs) in multiple myeloma (MM) registrational trials shows the need for further research to determine the most appropriate approaches for statistical and analytical methodologies for PRO data in MM trials. Writing in Blood Cancer Journal, the researchers say they found substantial
Devices
FDA’s Medical Device Single Audit Program (MDSAP) has released a document, Guidelines on the Use of Quality Management System—Medical Devices—Nonconformity Grading System for Regulatory Purposes and Information Exchange. The guideline is intended for regulatory authorities and auditing organizations participating in or using the results of the MDSAP.
Drugs
CDER director Patrizia Cavazzoni is scheduled to deliver a keynote address at the 13th Annual Sentinel Initiative Virtual Public Workshop 11/8-9. Co-hosted by the agency and the Duke-Margolis Center for Health Policy, the workshop will hear from the Sentinel community and leading experts about recent developments
Drugs
FDA has revised a guidance, Development of Abbreviated New Drug Applications During the Covid-19 Pandemic—Questions and Answers, which collects questions the agency has received from prospective applicants and applicants of ANDAs about generic drug product development and application assessment during the Covid-19 public health emergency. The 4/
Drugs
FDA says it is reconsidering the need for mandatory opioid prescriber education through the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). A 10/13-10/14 public workshop will be held in collaboration with the Duke-Margolis Center for Health Policy to allow stakeholders to provide input on aspects
Devices
FDA has cleared a joimax 510(k) for the EndoLIF Delta Cage and EndoLIF DoubleWedge Cage, intended for intervertebral body fusion procedures for various diseases of the lumbar spine, such as degenerative disc disease. The 3D printed titanium products are designed for bone ingrowth, and are fillable with bone or
Drugs
FDA says its review of Web sites and social media pages maintained by Genesis Nutrition Ultra Slim, doing business as Genesis Ultra Slim, Doral, FL, indicates that the firm markets its Genesis Ultra Slim Gold product intended for weight loss. A just-released 8/6 Warning Letter says the agency
Drugs
FDA has approved Impel NeuroPharma’s Trudhesa (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. A company announcement says Trudhesa uses the firm’s proprietary precision olfactory delivery technology to deliver the active ingredient quickly to the
Devices
FDA has approved a TransMedics Group PMA for its OCS Heart System for use with organs from donors after brain death. The OCS Heart is a portable, warm perfusion, and monitoring system designed to keep a donor heart at a human-like, metabolically active state, the company says. By monitoring
FDA Policy/General
Federal Register notice: FDA is correcting an 8/10 notice announcing a 9/17 Pediatric Advisory Committee meeting. It was published with the incorrect docket number and end time of the meeting. This document corrects those errors. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Reclassification Petitions for Medical Devices” (OMB Control Number 0910-0138). To change a device classification, FDA can initiate a reclassification, or an interested person can petition FDA to reclassify a device based on new information. The FDA
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Labeling Requirements for Prescription Drugs ” (OMB Control Number 0910-0572). The collection supports FDA regulations that set general requirements and specific content and format requirements. It is being revised to include the estimated “burden” associated with regulations