Human Drugs
STAQ Pharma Inspection FDA-483 Released
FDA releases an FDA-483 with five observations from an inspection at STAQ Pharma.
Human Drugs
GDUFA 3 Looks at Approving ANDAs Earlier
FDA and the generic drug industry each offer proposals to advance quicker ANDA approvals.
Medical Devices
Payments to Docs Correlate with ICD Choices: Study
Researchers say there is a correlation between medical device company payments to doctors and the selection of defibrillator devices to be implanted.
Human Drugs
BMS Psoriasis Drug Posts Favorable Trial Results
Bristol Myers Squibb announces positive results from POETYK PSO-1, a pivotal Phase 3 trial evaluating deucravacitinib, a novel, oral, selective tyrosi...
Human Drugs
CGMP Violations at Cosmax USA
FDA warns Cosmax USA about CGMP violations in its production of finished drugs.
Medical Devices
Digital Health Center of Excellence Roadmap Explained
An FDA Webinar listening session discusses the role and operations of the new Digital Health Center of Excellence.
Medical Devices
Medtronic Class 1 Recall of Rashkind Balloon Catheters
Medtronic begins a Class 1 recall of its Rashkind Balloon Septostomy Catheters because of device quality issues that may lead to the device breaking/s...
Human Drugs
Immusist Selling Unapproved, Misbranded New Drugs
FDA warns Immusist that it is selling unapproved and misbranded new drugs.
FDA General
FDA Resisting Civil Service Executive Order: Report
Politico reports that FDA and other health agencies are trying to fight an Executive Order that could make it easier for the Trump administration to f...
Biologics
Young Center Illegally Marketing Stem Cell Product: FDA
FDA warns the Young Foundational Health Center that it is illegally marketing stem cell products for a variety of diseases and conditions.
