Devices
A 6/5-6/7/2023 FDA inspection at Sonesta Medical AB in Solna, Sweden, found Quality System Regulation violations in the firm’s manufacturing of a radiographic table and two cystometric tables. A just-released 9/22/2023 Warning Letter says the specific violations were failing to establish and
Devices
FDA has published a guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, with recommendations for sponsors, investigators, and other stakeholders on the use of digital health technologies (DHTs) for remote data acquisition. The document defines a DHT as a system that uses computing platforms, connectivity, software, and/
FDA Policy/General
FDA has published a guidance, Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species. The document outlines the basic requirements and special considerations for approval of new animal drugs intended for minor uses in major species or for use
Drugs
FDA has issued a complete response letter for the Amgen sNDA that sought full approval for its Lumakras (sotorasib). The company says the agency’s review was based on the CodeBreak 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-
FDA Policy/General
Ferdic, Inc., publisher of Dickinson's FDA Webview, wishes all readers Happy Holidays and a bright and prosperous New Year. Our newsroom is closed until Tuesday, January 2, 2024.
Drugs
FDA has approved a Merck NDA for Welireg (belzutifan) for treating patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). Approval was based on data
Drugs
FDA has approved a Glaukos Corp. NDA for iDOSE TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for reducing intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. The product is designed to deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of the indications for mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) for Pharmacyclics Imbruvica (ibrutinib) capsules and tablets that were approved, respectively, under NDAs 205552 and 210563. The action follows the company’s decision earlier this year to voluntarily withdraw the
FDA Policy/General
Federal Register notice: FDA has sent to OMB an information collection proposal entitled “A Survey on Quantitative Claims in Direct-to-Consumer (DTC) Prescription Drug Advertising.” DTC prescription drug advertising may make quantitative claims about a drug’s efficacy or risks, and the agency has research and guidance available that
Devices
FDA has updated its “Risks and Complications of Breast Implants” Web page that clarifies information about implant removal and adds ultrasound as an acceptable alternative imaging device for screening for implant rupture for asymptomatic patients to the “Silicone Gel-Filled Implant Rupture” page. The agency also added a new subsection
FDA Policy/General
FDA has released a draft guidance entitled “Priority Zoonotic Animal Drug (PZAD) Designation and Review Process.” FDA says that a PZAD is defined as a “new animal drug, that alone or in combination with one or more other animal drugs, has the potential to prevent or treat a zoonotic disease
Biologics
FDA investigators cited GMP issues during a September inspection at Moderna’s primary facility in Norwood, MA, according to a Reuters report based on a related Form FDA-483 the news service obtained under a Freedom of Information Act request. The 9/11-21 inspection of the facility that makes
FDA Policy/General
FDA has sent Warning Letters to nine manufacturers and distributors of unapproved and misbranded antimicrobial animal drugs. An agency statement says FDA is concerned because the products contain antimicrobials that are important in human medicine. Using them without medical oversight contributes to the development of antimicrobial resistance, it says. The
Devices
FDA says it has begun participating in three new collaborative communities in the medical device ecosystem. An agency statement says a collaborative community is “a continuing forum in which private- and public-sector members, which can include FDA, work together on medical device challenges to achieve common objectives and outcomes.
Drugs
Republicans on the House Energy and Commerce Committee say there has been no response from FDA to their 7/18 request for information and documents about the agency’s foreign drug inspection program. In a 12/13 follow-up letter to FDA commissioner Robert Califf, the committee leaders say they
Devices
FDA has approved an Abbott PMA for its automated GLP systems Track, which is intended to support high-volume laboratory needs and maximize productivity. The device features an “intelligent self-propelled single sample carrier – called CAR,” according to the company. “Samples move independently, not attached to rigid, fixed mechanized track
Devices
FDA has approved a Medtronic PMA for the PulseSelect Pulsed Field Ablation (PFA) System for treating both paroxysmal and persistent atrial fibrillation (AF). The company says this is the first PFA technology to receive FDA approval. Approval was based on data from the PULSED AF study, which showed a 0.
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Adam Michael Nagy for a period of 15 years from importing any drug into the U.S. FDA based the action on Nagy’s conviction related to illegally importing Schedule I and II drugs while he was the owner and operator
FDA Policy/General
A lengthy Bloomberg Law report says a review of FDA records shows the agency is doing little to cut down on misleading drug claims on social media, despite having released draft social media guidelines in 2004. The report says that since issuing the draft guidance, the agency has “done little
Drugs
The Massachusetts federal court has approved a consent decree of permanent injunction against Pharmasol Corp. and its president Marc Badia for distributing adulterated drugs. An FDA statement says a complaint that was filed with the consent decree by the Department of Justice says the company and Bardia failed to: (1)
Drugs
FDA has placed a clinical hold on three CARsgen Therapeutics clinical trials due to chemistry, manufacturing and controls questions. As a result, trials evaluating CT053, CT041, and CT071 are on hold “pending resolution of the findings following an inspection of the manufacturing site located in Durham, NC,” a company release
Drugs
Four stakeholders are raising technical questions, concerns, requests for clarification, and comments on an FDA draft guidance on quality considerations for topical ophthalmic drug products. In its comment, the Consumer Healthcare Products Association says it respects the need for the guidance, especially given recent global concerns about contaminated ophthalmic drug