Drugs
An FDA reinspection of Alvotech’s Iceland manufacturing facility has resulted in a Form FDA-483 with one inspection finding. A 2023 inspection at the facility cited eight GMP deficiencies and led to a complete response letter (see story) that delayed the approval of the company’s Humira biosimilar, AVT02,
FDA Policy/General
Federal Register notice: FDA is announcing a 3/5 Medical Imaging Drugs Advisory Committee meeting to review a Lumicell NDA for pegulicianine for injection. The optical imaging drug constituent of the company’s drug/device combination product has a proposed indication for use in patients with breast cancer to assist
Devices
FDA has approved MRI labeling on Abbott’s dorsal root ganglion (DRG) stimulation therapy, the Proclaim DRG neurostimulation system, which allows patients to receive full-body MRI scans while the device is implanted. The device is intended to provide targeted relief for people with complex regional pain syndrome (CRPS) Types
Drugs
FDA has accepted for review a Novocure PMA that seeks approval for the use of tumor treating fields (TTFields) therapy together with standard systemic therapies for treating non-small cell lung cancer following progression on or after platinum-based therapy. The submission is based on data from the LUNAR study
Devices
In a joint 1/18 statement, CDRH director Jeff Shuren and Centers for Medicare & Medicaid Services (CMS) acting chief medical officer and acting director of the Center for Clinical Standards and Quality Dora Hughes say both agencies support an FDA 10/2023 proposed rulemaking to regulate laboratory-developed tests.
FDA Policy/General
Federal Register notice: FDA has announced that an information collection entitled “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations” has been approved by OMB. The approval expires on 12/31/2026. To view the notice, click here.Federal Register notice: FDA has announced that
Drugs
Attorneys Chad Landmon and Aaron Savit (Axinn, Veltrop & Harkrider) say the Supreme Court heard oral arguments in two cases this week that appeared to signal the court is likely to restrict, if not eliminate, the so-called Chevron deference under which courts have given deference to executive branch agencies
Devices
CDRH says that in 2023 it gave marketing authorization to 124 novel devices, excluding emergency use authorizations, the highest on record in the Center’s history. “CDRH continues to see high numbers of novel devices coming to market,” the Center’s 2023 annual report says, “with an almost five-fold
Drugs
Health Canada says U.S. officials have reassured Canadian health minister Mark Holland that the U.S. does not intend to create any challenges for that country on drug access or shortage through FDA’s approval of a Florida program to import drugs from Canada. FDA approved the Florida plan
Devices
CDRH Office of In Vitro Diagnostics (OIVD) director Timothy Stenzel has retired and a national search is underway to fill the vacant position. Stenzel joined FDA 7/2018 after long careers in both academics and industry, which included oversight of test development for both Clinical Laboratory Improvement Amendment labs and
Drugs
FDA has published a guidance, Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act, to assist supply chain stakeholders, particularly trading partners, with requirements for enhanced drug distribution security at the package level that took effect 11/27/2023. The document clarifies the enhanced
Drugs
FDA has issued Satsuma Pharmaceuticals a complete response letter on its NDA for STS101 (dihydroergotamine nasal powder), an investigational product for the acute treatment of migraine with or without aura in adults. The letter said the application cannot be approved in its present form due to chemistry, manufacturing, and controls
Devices
Percussionaire has recalled its Distal Phasitron, part: S20020, for use with the Percussionaire VDR-4 ventilator control driver due to the potential for the breathing circuit reservoir bag to be assembled at the wrong attachment point, which could result in less than optimal therapy. An FDA recall notice attributes the
Devices
FDA says the Megadyne Medical Products 12/8/2023 recall (correction) of four Mega Soft patient return electrode models is Class 1. An agency notice says the recall was to update the instructions for use and product labeling to restrict the use of the device to patients aged 12 and
Devices
At the request of Sens. Dick Durbin (R-IL) and Richard Blumenthal (D-CT), the Government Accountability Office (GAO) will look into FDA’s role and actions in oversight of medical device recalls, and especially the Philips Respironics recall of breathing machines. The Pittsburgh Post-Gazette, which worked with ProPublica
Devices
Medtronic says it supports FDA efforts to further enhance industry standards for pulse oximeters and to reduce potential health disparities related to using the devices by considering skin pigmentation, race, and ethnicity. Commenting on an agency discussion paper on the topic, Medtronic says that while there is still work to
FDA Policy/General
Speaking at the Consumer Technology Association’s “Ask A Commissioner” program at last week’s Consumer Electronics Show in Las Vegas, FDA commissioner Robert Califf said the agency can’t be solely responsible for effectively regulating products with adaptive algorithms that can learn and change. “If you have an algorithm
Drugs
FDA has granted a marketing authorization for DermaSensor's real-time, skin cancer evaluation system. The device uses the company’s AI-powered spectroscopy technology to “non-invasively evaluate cellular and subcellular characteristics of a lesion in question for skin cancer,” the company says. “The wireless, handheld device then
Drugs
FDA say it has extended the shelf life of Emergent BioSolutions’ newly manufactured Narcan (naloxone HCl) 4 mg nasal spray products from three years to four years. “This action was taken at the request of the FDA and is the latest of multiple steps the agency has recently taken to
Drugs
FDA has recommended to the Drug Enforcement Administration that marijuana be rescheduled from a Schedule 1 drug to a Schedule 3 drug under the Controlled Substances Act. Attorneys at Keller and Heckman write in a National Law Review post that the final decision ultimately will rest with DEA. The attorneys
Drugs
FDA has granted Nurix Therapeutics a fast track designation for NX-5948, a highly selective degrader of Bruton’s tyrosine kinase (BTK) for treating adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two lines of therapy, including a BTK inhibitor and a
FDA Policy/General
Federal Register notice: FDA has revised an information collection entitled “Premarket Notification for a New Dietary Ingredient (NDI) — 21 CFR 190.6.” Its collection is revised based on recommendations in a 2016 guidance entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” To view the notice, click here.