Drugs
FDA has published a guidance, Conducting Remote Regulatory Assessments—Questions and Answers, to help enhance the industry’s understanding of such assessments, thus facilitating the process for FDA conducting the assessments. The document says the term Remote Regulatory Assessment (RRA) is used to describe a category of activities for which
Devices
FDA has released a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The document applies to devices with cybersecurity considerations, including but not limited to those that have a device software function or that contain software (including firmware) or programmable logic, and it
Drugs
FDA has granted regenerative medicine advanced therapy designation for enGene Holdings’ detalimogene voraplasmid, the company’s lead investigational therapy to treat high-risk, Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ. A company statement describes detalimogene as a novel non-viral gene-based immunotherapy for
Drugs
Viatris says it will submit an NDA later this year for its MR-141 (phentolamine ophthalmic solution 0.75%) for treating presbyopia based on just-released data from the Phase 3 VEGA-3 trial. Presbyopia is a progressive vision condition affecting older adults that reduces their ability to focus on
Drugs
A 3/4-3/6 FDA inspection at the Sterling Distributors wholesale distribution facility in Coral Springs, FL, found significant violations of Drug Supply Chain Security Act (DSCSA) requirements. A 6/5 Warning Letter says the specific violations were: * engaging in wholesale distribution of prescription drugs without being appropriately licensed;
Drugs
FDA has released a final guidance entitled “Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment.” The document provides FDA’s current recommendations regarding the development of drugs to support an indication for the treatment of early Lyme disease as manifested by erythema migrans (EM). The guidance
Drugs
FDA has approved an updated label for Eli Lilly’s Amyvid (florbetapir F 18 injection) for brain imaging to estimate amyloid plaque density in patients with cognitive impairment being evaluated for Alzheimer’s disease and other causes of cognitive decline. The label update includes: * Revising how Amyvid can be used
Biologics
FDA has required and approved updates to the prescribing information for Pfizer’s Comirnaty Covid-19 mRNA vaccine and Moderna’s Spikevax Covid-19 mRNA vaccine to include new safety information about the risks of myocarditis and pericarditis following their administration. The warning on myocarditis and pericarditis in the vaccines’
Drugs
The staff of the online newsletter Global Biodefense raises a concern that FDA’s recent action stopping clinical trials that involve shipping participants’ biological samples to laboratories in China and other “hostile” countries can cripple biomedical innovation and progress in the U.S. “The stated concern is that overseas sample
Drugs
FDA has granted Syndax Pharmaceuticals a priority review of its supplemental NDA for Revuforj (revumenib) as a treatment for relapsed or refractory (R/R) acute myeloid leukemia (AML) with mutant NPM1 (mNPM1) — the most common genetic alteration found in adult AML patients. The agency has set a 10/25 user
FDA Policy/General
Former Rep. John Doolittle (R-CA) says the restructuring underway at FDA, while well-intentioned, risks “undermining the very innovation and domestic capacity the president seeks to promote.” Writing for The Hill, Doolittle, who served on committees with FDA oversight, says the elimination of 3,500 full-time FDA employees,
Devices
FDA has approved an InspireMD PMA for its CGuard Prime Carotid Stent System for treating carotid artery stenosis. The device is described as a novel mesh-covered stent designed to improve patient safety through sustained embolic protection. The device’s approval is supported by data from the company’s C-
Devices
Cook Medical has recalled (Class 1) its Beacon Tip 5.0 Fr Angiographic Catheter because it may experience tip separation. The issue was identified through field complaints, with users reporting tip separation occurring both prior to and during patient contact, a recall notice says. “If an affected product is used,
Drugs
Nektar Therapeutics is reporting promising results from a mid-stage clinical trial of its experimental therapy rezpegaldesleukin for patients with moderate-to-severe atopic dermatitis. The therapy met all primary and key secondary endpoints in a 16-week analysis of the global Phase 2b REZOLVE-AD study, it says. The
Devices
FDA has alerted healthcare providers to agency import alerts for certain medical devices manufactured by Olympus Medical Systems and its subsidiaries. An online notice says the alerts apply to specific models of the firm’s uteroenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors. “Despite extensive and ongoing efforts to address compliance
Drugs
Usona Institute chief medical officer Michael C. Davis is returning to CDER as the Center’s deputy director after being gone two and a half years, according to several media reports. He left the agency 12/2022 after serving almost seven years as a clinical team leader in CDER’s
Drugs
University of Pennsylvania Perelman School of Medicine associate professor of medical ethics and law Holly Lynch says the new FDA Commissioner’s National Priority Voucher (CNPV) program raises the question of how fast is too fast for FDA drug review. Writing online for MedPageToday, Lynch says a deeper look at
Drugs
The U.S. House Appropriations Committee 6/24 advanced in a 35 to 27 vote FDA’s fiscal year 2026 spending bill. The bill is in line with the Trump Administration’s budget proposal that would decrease agency spending by 4% ($271 million) to $6.8 billion. This includes $3.
Devices
FDA has issued a safety alert on Medtronic subsidiary Given Imaging and certain Bravo CF Capsule delivery devices, which are designed to place and attach a pH monitoring capsule to the esophagus to assist a physician in diagnosing clinical gastroesophageal reflux. The alert says Medtronic has told customers that the
Drugs
FDA has issued a safety communication about two reports of fatal acute liver failure following treatment of non-ambulatory pediatric male Duchenne Muscular Dystrophy patients with Sarepta Therapeutics’ Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus vector-based gene therapy. The safety alert comes after the company said last week
Drugs
An FDA review of records submitted by Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi in Istanbul, Turkey, in response to an agency 9/4/2024 request, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s manufacturing of over-the-counter drug
Devices
A 1/20-1/23 FDA inspection at Aju Pharm Co. Ltd. in Seongnam-Si, Gyeonggi, South Korea, found Quality System (QS) and Medical Device Reporting (MDR) violations in the company’s manufacturing of the Class 2 Fixone Hybrid Knotless Anchor and the Class 2 Fixone Biocomposite Anchor. A just-