Drugs
Sens. Marco Rubio (R-FL) and Angus King (I-ME) are urging FDA to develop clear regulatory guidelines for advanced manufacturing technologies (AMT) for drugs. In a statement (contains the text of their letter to FDA commissioner Robert Califf), the senators say that with “insufficient levels of domestic pharmaceutical manufacturing,
Biologics
The Institute for Clinical and Economic Review (ICER), a private, independent, nonprofit research institute, says that while it applauds FDA’s continued effort to create policies and guidance to enhance greater diversity in clinical trials, it is concerned about the stated intended goal of a draft guidance on diversity action
Drugs
FDA has approved a new indication for Merck’s Keytruda (pembrolizumab) with pemetrexed (Lilly’s Alimta) and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM). An agency statement says efficacy was investigated in the KEYNOTE-483 trial with the primary outcome measure of
Drugs
Congresswoman Nanette Barragán (D-CA) has reintroduced the Prompt Approval of Safe Generic Drugs Act, legislation that would expand access to lower-cost generic drugs by removing hurdles in the drug approval process. “These barriers otherwise prevent the Food and Drug Administration (FDA) from approving certain follow-on products that
Drugs
Applied Therapeutics says that following a late-cycle review meeting with FDA on the company’s NDA for govorestat to treat classic galactosemia, the agency no longer sees a need for a 10/2024 advisory committee meeting that had been scheduled and is moving forward with its priority review toward
Devices
Smiths Medical is recalling (Class 1) several lots of its Bivona Neonatal/Pediatric and Adult Tracheostomy tubes due to a manufacturing defect that may cause the device’s securement flange to tear. “The use of affected products may cause serious adverse health consequences, including lack of proper ventilation, loss of
Biologics
FDA has approved AstraZeneca’s Fasenra (benralizumab) for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated vasculitis that can result in damage to multiple organs. The approval was based on data from the noninferiority MANDARA Phase 3 trial published in The New England Journal of
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice.” The document provides recommendations on streamlined protocols and procedures for integrating research into routine clinical practice. It also addresses sponsor roles and responsibilities and discusses a
Biologics
FDA has published a guidance, Conducting Clinical Trials with Decentralized Elements, with recommendations for sponsors, investigators, and other interested parties about implementing decentralized elements in clinical trials. The document says decentralized elements can include telehealth, visits with trial personnel, in-home visits with remote trial personnel, or visits with local
Drugs
A 1/25-1/29 FDA inspection at the TJA Health drug manufacturing facility in Joliet, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 7/17 Warning Letter says the specific violations were: * failure to test samples of each component for
Drugs
A 6/12-6/16/2023 FDA inspection at the Quality CDMO drug manufacturing facility in Fort Worth, TX, found the company produces drug products that are legally considered to be unapproved new drugs. A 9/11 Warning Letter reviews claims made for five drug products that are not generally
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) is asking FDA to consider a phased approach to enforcing the Drug Supply Chain Security Act (DSCSA) in light of the mutual dependence among trading partners in the supply chain. The association’s 9/12 comment letter says its members have been working
Drugs
FDA has approved Novartis’ Kisqali (ribociclib) for combination use with an aromatase inhibitor for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) Stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative
Drugs
FDA has removed a partial clinical hold against Vigil Neuroscience and its ongoing Phase 1 clinical trial of VG-3927, a small molecule targeting human triggering receptor expressed on myeloid cells 2 (TREM2) agonist for treating common neurodegenerative diseases associated with microglial dysfunction, particularly Alzheimer’s disease. The decision to
Drugs
An FDA review of records supplied by Industria Farmaceutica Nova Argentia in Milan, Italy, a manufacturer of over-the-counter drugs, found violations of current good manufacturing practice (CGMP) regulations. A 9/9 Untitled Letter says specific violations were: * failure to have, for each batch of drug product, appropriate laboratory
Drugs
Merck and Daiichi Sankyo say their HERTHENA-Lung02 Phase 3 trial evaluating patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment met its primary endpoint (progression-free survival (PFS)).The trial data demonstrated
FDA Policy/General
Federal Register notice: FDA is announcing an 11/20-21 Digital Health Advisory Committee meeting to discuss total product lifecycle considerations for generative artificial intelligence (AI)-enabled devices. The agency is seeking input on how generative AI may impact device safety and effectiveness, and on premarket performance evaluations, risk management,
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Considerations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs.” The document provides recommendations to sponsors who are planning global clinical development programs for drugs intended to treat cancer. It provides advice for the planning, design, conduct, and
FDA Policy/General
Federal Register notice: FDA is classifying quantitative viral nucleic acid tests for transplant patient management into Class 2 (special controls). The action was based on a 2020 Roche Molecular Systems request for de novo classification of its cobas EBV. The agency says the device is intended for prescription use in
Drugs
FDA has published a guidance, Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice, that is intended to support the conduct of randomized clinical trials (RCTs) with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice. The
Devices
FDA has issued a safety alert about an increased risk of thigh bone fracture after surgery (postoperative periprosthetic femoral fracture) with the use of the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Hip System). In July, the company began a recall to update the device’
Drugs
FDA has released a 10-observation Form FDA-483 issued to SSM St. Clare Health Center a for GMP deficiencies documented during a February inspection at an outsourcing facility in Fenton, MO. For example, the agency says the firm failed to establish written procedures for production and process controls. Investigators