Devices
FDA has issued two documents with answers to frequently asked questions about medical device recalls and reports of corrections and removals. The first, Medical Device Recalls and Reports of Corrections and Removals, Part 7, Part 806: Frequently Asked Questions answers common questions about medical device recalls and reports of medical
Biologics
FDA has granted interchangeable biosimilar status to Celltrion’s Yuflyma (adalimumab-aaty), a high-concentration, citrate-free biosimilar copy of AbbVie’s Humira. The designation permits pharmacists to substitute Yuflyma for Humira without requiring a new prescription from a healthcare provider. The original Yuflyma BLA was approved 5/2023 for
Drugs
Under a 4/15 presidential Executive Order, FDA has 180 days to issue a report with recommendations to (1) accelerate the approval of generics, biosimilars, combination products, and second-in-class branded medications; and (2) improve the process through which prescription drugs can be reclassified as over-the-counter medications.
Drugs
A new citizen petition is asking FDA to amend the requirements under 21 CFR Part 211 (current good manufacturing practice for finished pharmaceuticals) to mandate the use of separate sampling logbooks or equivalent electronic logs for all sampling activities, including raw materials, in-process materials, finished products, and stability samples.
Drugs
The 9/18-9/19/2024 Global Summit on Regulatory Science was hosted by FDA with the theme “Is Regulatory Science Ready for Artificial Intelligence?” A report from the conference, published in the open-source NPJ Digital Medicine, includes 10 key principles for regulating artificial intelligence (AI) described by former
Devices
Three CDER and Digital Health Center of Excellence staffers say advancing the use of digital health technologies (DHTs) is a priority for FDA. “We recommend engaging early with FDA when planning to integrate DHTs into a clinical investigation to design a trial that will provide meaningful results,” the three write
FDA Policy/General
Recent FDA layoffs are raising red flags across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approvals and challenge companies’ ability to maintain GMP compliance. Pre-approval inspections are likely to suffer from staff shortages, according to a Morgan Lewis legal update.
Drugs
FDA says its review of a Web site maintained by the Naturista Store in Downey, CA, determined that the company is illegally marketing the Advance King product for sale in the U.S. A just-released 3/26 Warning Letter says Advance King is an unapproved new drug that is
Drugs
An 11/4-11/8/2024 FDA inspection at the PMS4PMS drug manufacturing facility in Clarence, NY, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/7 Warning Letter says the specific CGMP violations were: * failure to have, for each batch of drug product,
Drugs
FDA has cleared an eGenesis and OrganOx IND for a first-in-human clinical trial to evaluate a novel perfusion system using a genetically engineered porcine liver to treat patients with acute-on-chronic liver failure and no transplant option. An eGenesis statement says its EGEN-5784, a human-compatible,
Drugs
Sanofi says preliminary results from a Phase 2 (NCT05421598) study of amlitelimab in adults with moderate-to-severe asthma show that the “primary endpoint of annualized exacerbation rate at Week 48 was not met at the highest dose level, leading to nominal significance at the medium dose. However, it says
Drugs
Mural Oncology says it is discontinuing all clinical development of its lead drug candidate, nemvaleukin alfa, following disappointing results from two key trials in melanoma and ovarian cancer. The company also said it will begin exploring strategic alternatives to “maximize shareholder value.” The action follows a review of topline data
Devices
FDA has granted Click Therapeutics a de novo marketing authorization for its prescription digital therapeutic, CT-132, which it describes as the first prescription digital therapeutic for preventing episodic migraine. The company says it is intended for adjunctive use alongside acute or other preventive treatments for migraine. The device “delivers
Devices
FDA has cleared a TytoCare 510(k) for its Tyto Insights for Rhonchi Detection, an artificial intelligence (AI)-based device for detecting, during a virtual exam, all three major abnormal lung sounds — wheezes, crackles, and rhonchi. The company says the the diagnosis of these abnormal lung sounds presents a recognized
Drugs
Researchers at China’s Capital Medical University say that compared to the U.S., China appears to take a more stringent regulation toward using surrogate endpoint response rate (RR) data to support cancer drug approvals. In an open-access Cancer Medicine article, the researchers discuss their analysis of all cancer
Drugs
Researchers from FDA and several hospitals say there is increasing interest in using patient-reported outcomes (PROs) as endpoints in heart failure trials and regulatory bodies have shown a willingness to consider heart failure drugs and devices for approval based on improvement in PROs. Writing in the journal Circulation, the
Devices
Harmed Americans for Reforms in Medical Device Safety (HARMS) is asking FDA to recall all Humacyte Symvess vascular graft products and withdraw its approval of the Symvess BLA. The 4/10 petition cites eight cases with ATEV (acellular tissue-engineered vessel) blowouts or disruptions generally associated with major, life-threatening
Devices
FDA has cleared a Bright Uro 510(k) for its Glean Urodynamics System, a wireless, catheter-free ambulatory urodynamics device designed to support clinical decision-making for patients with lower urinary tract dysfunction. About 80 million Americans suffer from voiding problems, including overactive bladder, urinary incontinence, enlarged prostate and neurogenic
Drugs
FDA has approved Mirum Pharmaceuticals’ tablet formulation of Livmarli (maralixibat) for treating cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis. The approval “allows flexibility for patients and physicians, with the liquid dosing used by the youngest patients and a convenient one-tablet per dose option for
Drugs
Ironwood Pharmaceuticals says it will conduct a new Phase 3 clinical trial for its investigational drug apraglutide, following recent discussions with FDA on the drug’s approval path for treating short bowel syndrome with intestinal failure (SBS-IF). FDA is requiring a confirmatory trial after raising concerns with the earlier
Drugs
Pfizer says it is discontinuing development of danuglipron, an experimental oral GLP-1 receptor agonist being evaluated for chronic weight management. Despite promising results from recent dose-optimization studies, including successful achievement of key pharmacokinetic goals and a formulation with potential Phase 3 viability, the company opted to stop further
Drugs
FDA says it seized several hundred units of counterfeit versions of Novo Nordisk’s Ozempic (semaglutide) 1mg injection that had entered the U.S. drug supply chain. The fake drugs were not distributed through the company’s authorized supply channels, according to an agency alert. Novo Nordisk first alerted the