Biologics
Emergent Biosolutions says it is establishing a quality enhancement plan for its troubled Bayview manufacturing facility in Baltimore, MD. A just-released 4/30 submission to FDA was the company’s initial response to an FDA-483 that detailed nine concerns at the facility. The agency inspection followed reports of
Devices
FDA has granted iStar Medical an IDE to begin a pivotal trial with its Miniject implant in over 350 patients with primary open angle glaucoma. The STAR-V trial will evaluate the device’s efficacy by the mean reduction in eye pressure, as well as the proportion of patients achieving
Devices
FDA has cleared a Palliare 510(k) for the END-200 tubeset that expands the use of its EVA15 continuous pressure insufflation technology from laparoscopic surgery to endoscopic and endoluminal surgery. The EVA15 insufflator and smoke evacuation system is designed to create a safer operating room environment and deliver insufflation
Drugs
BIO says an FDA Covid-19 emergency guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the Covid-19 Public Health Emergency, provides clarity on inspection activities during the Covid-19 pandemic and is an important step in discussions on modernizing inspectional activities. The association’s 7/
FDA Policy/General
FDA has approved VetDC’s Tanovea (rabacfosadine injection) to treat lymphoma in dogs. The company had been previously granted conditional approval under statutory provisions related to drugs intended for uncommon diseases or conditions in major animal species (minor uses) or for use in the minor species of animals under the
Devices
FDA says patients, caregivers, and healthcare providers should be aware of potential mechanical failures and concerns about tissue incompatibility associated with components of several specified NuVasive Specialized Orthopedics MAGEC devices. An agency safety communication refers to a company 2/2020 notice recalling its MAGEC devices to address a mechanical component
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site, Facebook page, and other materials relating to Scarsdale Integrative Family Medicine (doing business as See Beyond), Scarsdale, NY, has determined that the practice markets a cellular product that appears to be derived from human umbilical
FDA Policy/General
Federal Register notice: FDA has determined that Merck’s Stromectol (ivermectin) tablets, 6 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. The product is indicated
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says a professional animated banner for Amgen’s Neulasta (pegfilgrastim) injection for subcutaneous use makes false or misleading claims and representations about the drug’s benefits and thus misbrands it. A 7/7 Notice of Violation says the FDA Bad Ad Program
Drugs
FDA has denied a 5/9/13 Janssen petition asking that the agency apply specific bioequivalence parameters to any ANDA submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FFDCA) or NDA submitted under section 505(b)(2) that references the company’s Invega Sustenna (paliperidone
Drugs
FDA has lifted a partial clinical hold against Ryvu Therapeutics and its Phase 1b dose escalation clinical trial of RVU120 (also known as SEL120) in patients with relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. The hold was issued after Ryvu reported a patient death that might have
Drugs
A 7/8 petition submitted by an unidentified party is asking FDA to refuse to approve the NDA for United Therapeutics’ Tyvaso DPI, a dry powder inhalation formulation of treprostinil in the absence of additional clinical data demonstrating that it is safe for use in patients with certain chronic lung
Drugs
In a somewhat contentious interview with Stat News, FDA acting commissioner Janet Woodcock defended the agency’s decision to approve Biogen’s controversial Alzheimer’s treatment Aduhelm (aducanumab) but said: “It’s possible that the process could have been handled in a way that would have decreased the amount of
FDA Policy/General
FDA will hold its first FDA Inspectional Affairs Council meeting this week to discuss optimizing agency inspections on an enterprise- or cross-agency basis, according to associate commissioner for regulatory affairs Judy McMeekin. Speaking to an Alliance for a Stronger FDA update 7/14, she said the council comprises top
FDA Policy/General
CNN reports that the White House and CNN can’t agree over who should be nominated as commissioner of FDA. Sources told the network that acting commissioner Janet Woodcock is no longer the front-runner for the job due to objections from some Senate Democrats. “However,” the report says, “it
Drugs
The three senior CDER officials involved in the controversial approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease are defending their action as consistent with FDA accelerated approval requirements and the need of Alzheimer’s patients for new treatment options. Writing in a JAMA Internal Medicine Viewpoint column,
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is planning research to better understand the landscape of healthcare provider-directed promotion of prescription drugs at medical conferences in general and, more specifically, how elements of pharmaceutical booths in medical conference exhibit halls affect healthcare professionals’ perceptions of the drugs that
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs. The document notes that eligibility for conditional approval has been expanded beyond minor uses in major species and use in minor species to include certain major uses in major
Devices
FDA has cleared an EnsoData 510(k) for new capabilities and enhancements to its EnsoSleep product, an artificial intelligence-assisted sleep scoring program that automates event detection in polysomnography (PSG) and home sleep apnea tests (HSAT). “Our enhancements to EnsoSleep will help to further expand patient access to quality care
Drugs
Innoveix Pharmaceuticals has recalled several lots of sterile compounded drug products due to a lack of sterility assurance that was determined by a recent FDA inspection. “Administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threatening,” a
FDA Policy/General
Federal Register notice: FDA has announced that it has issued a priority review voucher to Mallinckrodt’s Stratatech unit after approving its material threat medical countermeasure product application — Stratagraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen—dsat). The product is indicated for treating adults with thermal burns containing
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Device Labeling Regulations” (OMB Control No. 0910-0485). The collection supports implementation of medical device labeling requirements governed by section 502 of the Federal Food, Drug, and Cosmetic Act. FDA says the revision was made to