Drugs
Senators Dick Durbin (D-IL) and Roger Marshall (R-KS) are urging FDA to take enforcement action against a planned direct-to-consumer (DTC) commercial that will run during the Super Bowl 2/9 which omits safety or side effect information. The commercial promotes Hims & Hers’ compounded version of
Devices
FDA has cleared a RapidAI 510(k) for its Lumina 3D, an automated 3D imaging reconstruction device designed to replace manual workflows with an artificial intelligence-powered approach. “Obtaining high-quality 3D images within minutes of a CTA [computed tomography angiography] scan marks a significant advancement and milestone in neuroradiology,
Biologics
FDA has granted Adicet Bio a fast-track designation for ADI-001 and its use in treating adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement. ADI-001 is described as an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for treating autoimmune
Devices
An FDA notice is alerting healthcare professionals and patients about medical device reports (MDRs) detailing “breast implant illness” with a variety of systemic symptoms that have been reported following reconstruction or augmentation with breast implants. “These symptoms include, but are not limited to, fatigue, problems with memory or concentration (brain
Drugs
FDA has approved an AbbVie NDA for Emblaveo (aztreonam and avibactam), a fixed-dose monobactam/β-lactamase inhibitor combination antibiotic. The intravenous antibiotic is approved for combination use with metronidazole in patients 18 years and older who have limited or no alternative options for treating complicated intra-abdominal infections, including
FDA Policy/General
A group of 24 Senate Democrats have written HHS acting secretary Dorothy Fink asking the Department to end the ongoing and unprecedented freeze on all external communications and funding at government health agencies, including FDA. “We write to express our deep concern over the Administration’s recent decision to freeze
Drugs
FDA has accepted for priority review an Insmed NDA for brensocatib for treating patients with non-cystic fibrosis bronchiectasis. The agency has set a review action target date of 8/12. The submission is based on data from the Phase 3 ASPEN study, which met its primary endpoint with both
Devices
FDA has issued an alert about Bard Peripheral Vascular’s Rotarex Atherectomy Systems because the helix portion of the device rotates at a high rate of speed and may be at risk of fracture or breakage when exposed to certain stress, wear, high temperatures, friction, or localized pressure. “Use of
Drugs
A Pacific Research Institute white paper explains why it believes drug manufacturers should present preemption claims when they are charged under state laws with failing to market as quickly as possible a drug that allegedly presents fewer side effects than other FDA-approved drugs already on the market. The paper
Drugs
A Cooley Alert says a recent 4th Circuit Court of Appeals decision in a Medicare fraud case may embolden the government to reject the “practice of medicine” defense whenever a healthcare practitioner uses an approved or cleared medical device for off-label uses, under the theory that any device that
Drugs
FDA has granted Onc.AI a breakthrough device designation for its Serial CT Response Score (Serial CTRS) AI model, which the company describes as an artificial intelligence (AI)-based prognostic tool that uses deep learning to analyze CT scans and stratify lung cancer patients into high- or low-mortality risk
Devices
FDA says the 12/31/2024 Medline Industries recall of integrated arterial catheters is Class 1. An agency notice says the recall was due to a manufacturing issue that caused excess material to be present on the catheter hub. “If a catheter with excess material at the hub is used,
FDA Policy/General
The White House is preparing an executive order to fire thousands of HHS employees, according to a Reuters report that says the story was broken by the Wall Street Journal based on anonymous sources. According to the Journal, Reuters says, the order could come as soon as next week and
Drugs
A Buchanan Ingersoll & Rooney petition asks FDA to impose two restrictions on ANDAs citing Waylis Therapeutics’ Tabloid (thioguanine) 40 mg tablets as the reference-listed drug. The 2/3 petition asks FDA to: * maintain and strictly apply the requirements of the current product-specific guidance (PSG) for thioguanine, which
Drugs
FDA has granted Bracco Imaging a fast-track designation for its BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection, which is being developed for detecting areas of active bowel inflammation in patients with Crohn’s disease. BR55 is described as a novel molecular imaging ultrasound contrast agent designed to specifically target
Drugs
An FDA review of the records it requested on 3/4/2024 from Imperial Palace Commodity—Dongguan—Co., Ltd., in Dongguang, Guangdong, China, a manufacturer of over-the-counter drugs, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/27 Warning Letter says the
Biologics
A 9/11-9/15/2023 FDA inspection at BioStem Life Sciences in Pompano Beach, FL, determined that the company manufactures cellular products derived from human umbilical cord and an amniotic membrane combined with amniotic fluid product. A 1/17 Warning Letter says that while such products are legally considered
Devices
FDA has issued a safety alert on certain diabetes devices (e.g., continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems) that rely on a smartphone to deliver critical safety alerts. Smartphone users with diabetes-related apps on their phones can configure alert settings to customize which alerts
Drugs
New York is the latest state to publicly express interest in developing a program to import drugs from Canada. That’s the word in a Bloomberg Law “Deep Dive” into the issue of drug importation. “State leaders are reviving talk of importing prescription drugs from Canada, even as U.S.
Drugs
Kura Oncology and Kyowa Kurin say they are on track to submit a second-quarter NDA for ziftomenib, described as a highly selective once-daily oral investigational menin inhibitor indicated to treat patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). A Kura statement reports positive results from the
Devices
FDA has granted Acrivon Therapeutics a breakthrough device designation for the ACR-368 OncoSignature assay, which the company describes as a multiplex immunofluorescence assay for identifying endometrial cancer patients who may benefit from ACR-368 treatment. The device is being developed to prospectively predict tumor sensitivity to ACR-368, described
Devices
Baxter Healthcare Corporation is recalling (Class 1 device correction) its Life2000 Ventilator System due to a nonconforming battery charger, which triggers a battery alarm and makes the ventilator inoperable. “This is a result of a failed crimping operation during manufacturing that caused the crimp to puncture the insulation of the