Devices
Philips Respironics has recalled (Class 1) its OmniLab Advanced + Ventilator because the device may experience an interruption or loss of therapy in case of a ventilator inoperative alarm. An interruption/loss of therapy could lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death, a recall
Devices
Members of the FDA Molecular and Genetics Panel of the Medical Devices Advisory Panel have recommended the approval of a Guardant Health PMA for the Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease. “The advisory committee’
Drugs
Pfizer’s Hospira drug unit is recalling (Class 1) several lots of buprenorphine HCl injection Carpuject units and labetalol HCl injection Carpuject units due to the potential for incomplete crimp seals. A recall notice says one customer complaint has been received on one leaking unit. “In the event that impacted
Drugs
FDA has cited Laurus Labs (Hyderabad, India) over GMP deficiencies following a 12/2023 inspection at the firm’s active pharmaceutical ingredient (API) manufacturing facility in Andhra Pradesh, India. During the inspection, the agency says in a just-posted untitled letter that it determined that the firm’s quality unit
Drugs
FDA has denied an Ipsen Pharmaceuticals 10/15/2019 petition asking that the agency take specific actions on any ANDA that references Ipsen’s Somatuline Depot (lanreotide acetate) subcutaneous solution. The FDA 5/21 response says Ipsen asked that FDA require: * ANDA applicants referencing Somatuline Depot to demonstrate bioequivalence through
Drugs
The FY 2023 GDUFA Science and Research Report says FDA awarded eight new grants and 12 new contracts during the fiscal year for innovative extramural research projects relevant to generic drugs. The agency also used its internal resources and expertise to conduct over 70 research projects designed to facilitate generic
Biologics
Responding to a question posed during a 5/23 hearing held by the House Energy and Commerce Committee Health Subcommittee, CDER director Patrizia Cavazzoni said FDA would benefit from having the authority to order mandatory recall of harmful drugs. “We have that authority for lettuce, but not for drugs,” she
Drugs
FDA has granted Theriva Biologics a fast-track designation for its lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. VCN-01 is described by the company as a systemically administered oncolytic adenovirus
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says there are four key, open FDA Reauthorization Act (FDARA) implementation issues that FDA should address. In its comment letter submitted to the docket for the Pediatric Oncology Subcommittee 5/22 meeting to discuss perspectives relating to implementation of FDARA, PhRMA identifies the
Drugs
Vyaire Medical is recalling (Class 1) its Twin Tube sample lines, which are used on the Vyntus CPX Cardiopulmonary Exercise Test, due to the potential for the nozzle separating during patient use. The tubes connect to the device’s dead volume trap adapter, which allows the continuous collection of gas
FDA Policy/General
Federal Register notice: FDA is making available a draft revised guidance entitled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1).” The document is intended to help ensure international harmonization of reproduction testing that is appropriate for the evaluation of effects on
Devices
FDA has approved a CorTec IDE to allow the University of Washington School of Medicine to conduct a study involving the closed-loop Brain Interchange Implant System. The study will investigate a “novel stroke rehabilitation treatment using cortical stimulation to enhance plasticity within the brain,” the company says. The study
FDA Policy/General
Federal Register notice: FDA is extending the comment period on its proposed rule entitled “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs.” The agency now will accept comments until 8/9. To view the notice, click here.
Drugs
Otsuka Pharmaceutical has terminated its development of the novel compound AVP-786 as a potential treatment for patients with agitation associated with dementia due to Alzheimer’s disease. The decision was based on results from a Phase 3 program that showed no statistically significant difference was observed between AVP-786
Devices
Members of the FDA Molecular and Genetics Panel of the Medical Devices Advisory Panel will be asked to vote 5/23 on the safety and effectiveness of the Guardant Health Shield blood-based colorectal cancer screening test. An agency executive summary distributed in advance of the meeting says Shield is
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of CDRH’s Medical Devices Advisory Committee notify it in writing. The agency is also requesting nominations for nonvoting industry representatives to serve on certain
Devices
Commenting on an FDA virtual public workshop about expanding the Accreditation Scheme for Conformity Assessment (ASCA), AdvaMed says it believes there is significant promise in the program and has suggestions intended to help ASCA achieve its promise now that the pilot is a permanent program. In its letter, the association
Drugs
FDA medical reviewers say there was an increased risk of hypoglycemia in patients with Type 1 diabetes taking Novo Nordisk’s Awiqli (insulin icodec) once-weekly insulin. The reviewers’ comments are in a briefing document released in advance of a 5/24 meeting of the agency’s Endocrinologic and Metabolic
Drugs
After a nine-year career at FDA, Oncology Drugs Division director Harpreet Singh has left the agency to join Precision for Medicine as chief medical officer, responsible for medical strategy and oversight. “The wealth of experience that Dr. Singh brings to Precision from over a decade of experience at the
Drugs
Public Citizen is suing FDA in DC federal court to force the agency to act on a six-year-old petition seeking revised labeling for selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) to warn of serious side effect risks. A Public Citizen statement says the revised
Devices
FDA says the Hologic 3/13 recall (correction, not product removal) of nine BioZorb markers due to complications and adverse effects with implanted devices is Class 1. An agency notice says the 53,492 devices recalled in the U.S. were distributed between 4/29/2019 and 4/1/2024.
Drugs
Medical device maker Magellan Diagnostics (Billerica, MA) has agreed to pay $40 million to resolve criminal charges relating to its concealment of a device malfunction that produced inaccurately low lead test results for potentially tens of thousands of patients. “As part of the criminal resolution, Magellan will plead guilty to