Regulatory Update — Week of Nov. 27, 2023
Over the past week, the FDA issued proposed rules to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals and to require premarket approval…
Eitan Medical Recalls Infusion Pumps for Failure to Detect Air in the Line
Eitan Medical’s recall of 1,323 infusion pumps — for a risk that the pump may fail to detect air in the line when running on battery power — has been…
FDA Chief Scientist Namandje Bumpus Named to Replace Janet Woodcock
Namandje Bumpus, currently chief scientist for the FDA, will replace Janet Woodcock as principal deputy commissioner, FDA Commissioner Robert Califf announced Wednesday. Source: Drug Industry Daily
AbbVie Plans $10.1B Acquisition of ImmunoGen to Speed Entry Into Ovarian Cancer Market
AbbVie and ImmunoGen today announced an agreement under which AbbVie will acquire ImmunoGen, and its flagship cancer therapy Elahere (mirvetuximab soravtansine-gynx) an antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer,…
Lack of Sterility, Lab Controls, Earns Kilitch Healthcare a Form 483
Kilitch Healthcare India received an FDA Form 483 citing lack of sterility, incomplete laboratory records and inadequate laboratory controls, inadequate validation of aseptic processes and unclean and insanitary buildings following…
Adcomm Cautions on Social, Emotional Risks Associated With Multi-Cancer Screening
Despite overall enthusiasm for the use of multi-cancer diagnostic (MCD) tests, several members of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee raised concerns about the…
Novo Nordisk Fights Fake Wegovy/Ozempic and Faces Mounjaro’s Superior Study Results
Novo Nordisk has filed complaints against two Florida-based compounding pharmacies for marketing unapproved versions of its semaglutide products, claiming the products are weaker in strength than labeling indicates and may…
Experts, FDA Debate Mortality as Endpoint for Multi-Cancer Diagnostic Trials
At an FDA advisory committee convened to gather insights on multi-cancer diagnostic (MCD) tests, the 10-member advisory panel veered off course when the topic of endpoints arose, voicing varying levels…
FDA Proposes PMA and New Classifications for Certain Wound Dressings, Washes
The FDA is proposing to classify for the first time certain wound dressings and liquid wound washes containing antimicrobials or other chemicals, an action that would also mean a premarket…
Vivos Gets FDA Nod for Sleep Apnea Oral Device, While Philips Wrestles With Yet Another CPAP Safety Issue
Vivos Therapeutics achieved a first in obtaining FDA clearance of its removable oral appliance for severe obstructive sleep apnea — an alternative to continuous positive airway pressure (CPAP) or surgical…
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