Drugs
An FDA review of records submitted by Guangzhou Four E’s Scientific Co., Ltd., in Guangdong, China, at the agency’s request, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 11/13 Warning Letter says the company’s quality control unit failed
Devices
Getinge/Maquet has issued a Class 1 recall (device correction) to inform users about important safety information for its VasoView HemoPro 2 Endoscopic Vessel Harvesting System (VH-4000 and VH-4001) due to complaints received for two failure modes experienced during use — a bent or detached heater wire, and silicone
Biologics
Four Ropes & Gray attorneys say the 9/27 9th Circuit Court of Appeals decision backing FDA regulation of stem cell treatment, which followed a 2021 similar ruling by the 11th Circuit, will make it harder for other clinics to argue that their procedures are exempt from agency oversight. Writing
Drugs
FDA has denied a Metacel Pharmaceuticals 8/18/2023 petition asking that the agency require ANDA sponsors relying on Ozobax (baclofen) oral solution as the reference-listed drug to conduct testing and provide data to address the safety of any flavoring ingredient and to reject any requests from generic drug
Drugs
FDA has published an International Council for Harmonization draft M15 guideline, General Principles for Model-Informed Drug Development. The document provides general recommendations for planning, model evaluation, and documentation of evidence derived from model-informed drug development (MIDD) and establishes a harmonized assessment framework, including associated terminology, for MIDD evidence.
Devices
FDA has granted MeMed a breakthrough device designation for its MeMed Severity test, intended for use in determining risk assessments in patients suspected of developing sepsis. The test is designed to “aid clinicians in rapid risk stratification and predicting disease progression, in conjunction with clinical assessments and other laboratory findings,
Drugs
Eli Lilly says data from its confirmatory Phase 3 BRUIN CLL-321 trial evaluating Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma met its primary endpoint of progression-free survival (PFS). The trial, which
Devices
FDA has cleared Pentax Medical 510(k)s for new models of its Pentax Medical Video Colonoscope EC34-i20cL and Pentax Medical Video Upper GI Scope. The new slim models feature advanced imaging, enhanced maneuverability with adjustable stiffness, and advanced ergonomics to help improve experiences of the medical professionals working
FDA Policy/General
Federal Register notice: FDA is making available a guidance entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions.” The document describes the electronic submission of certain data and information in standardized formats to assist with the planning
Devices
FDA is updating a Baxter recall (device correction) of its MiniCap Extended Life PD Transfer Sets used in hemodialysis based on recent recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain
Drugs
FDA has accepted for review a supplemental NDA for Nucala (mepolizumab) and its use as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease with an eosinophilic phenotype. The agency has set a user fee review action target date of 5/7/2025. The monoclonal antibody was
Drugs
FDA has approved a Cumberland Pharmaceuticals supplemental NDA for a simplified dosing regimen of its Acetadote (N-acetylcysteine for injection) product. Acetadote is an intravenous formulation of N-acetylcysteine indicated to prevent or lessen liver injury after ingestion of potentially toxic quantities of acetaminophen. “The newly approved dosing regimen simplifies
Drugs
Merck says the Phase 3 KEYLYNK-001 trial evaluating Keytruda (pembrolizumab) plus chemotherapy followed by maintenance with Lynparza (olaparib), with or without bevacizumab, as a first-line treatment for people with BRCA non-mutated advanced epithelial ovarian cancer met its primary endpoint of progression-free survival. However, the company says
Drugs
Agios says it has filed a supplemental NDA for an expanded indication for its Pyrukynd (mitapivat) for treating adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The pyruvate kinase activator is currently approved for treating hemolytic anemia in adults with pyruvate kinase deficiency. The submission
Devices
FDA has cleared an AngioDynamics 510(k) for the NanoKnife System for prostate tissue ablation. The clearance was based on data from the pivotal PRESERVE clinical study that evaluated the safety and effectiveness of the system in patients with intermediate-risk prostate cancer. The study met its primary effectiveness endpoint,
Drugs
AbbVie is announcing “positive topline results” from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as a flexible-dose monotherapy in early Parkinson's disease. The investigational D1/D5 dopamine receptor partial agonist is being evaluated as a once-daily treatment for Parkinson’s. Based on the results,
Drugs
Chimerix says that based on FDA feedback it plans to submit an NDA before the end of the year seeking accelerated approval for dordaviprone for treating recurrent H3 K27M-mutant diffuse gliomas. The aggressive and potentially lethal gliomas affect over 2,000 patients annually in the U.S, according to
Drugs
FDA has posted an 11-item Form FDA-483 from a 10/2023 Fresenius Kabi Oncology inspection at the company’s Pradesh, India manufacturing facility. Significant GMP deficiencies cited in the form are: * Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and
Drugs
FDA has released a final guidance entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions.” The document describes the electronic submission of certain data and information in standardized formats, which would include all pivotal studies used to
FDA Policy/General
Federal Register notice: FDA is announcing a 2/5 joint meeting of its Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee. Panel members are scheduled to discuss the findings of completed postmarketing epidemiologic studies that examined the serious risks and predictors of misuse,
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics.” The document provides information on the agency’s policies and procedures for the accelerated approval program, including which products may be eligible, the standards for granting approval, and
Devices
GE Healthcare has recalled (Class 1 instructions for use update) its Giraffe Omnibed Carestation and Incubator Carestation due to preliminary testing of newly manufactured devices that suggested higher levels of formaldehyde exposure for neonates in the first week of device use. The levels rapidly decrease after the first week of