Medline Industries recalls 2,980 medical convenience kits containing NAMIC angiographic rotating adapter syringes due to risk of adapter unwinding causing disconnection during use; distributed nationwide in US, Puerto Rico, Canada, Netherlands, and …
Cook Medical recalls 20 units of Arterial Pressure Monitoring Trays (APMY series) distributed worldwide due to expiration date labeling exceeding true shelf life, posing temporary health risks.
FDA draft guidance recommends next-generation sequencing methods for nonclinical safety assessment of investigational human genome editing products in gene therapy.
FDA holds public meeting on expanding nonprescription drug access and requests stakeholder comments; no specific deadline or financial impact stated for small businesses.
Fagron Compounding Services recalls 16,130 bags of vancomycin HCI and four other sterile products nationwide due to failed sterility assurance and potential port detachment risks.
Teva Pharmaceuticals USA recalls 62,136 cartons of Clonidine Transdermal System and two other products due to unapproved raw material use; Class II recall distributed within the U.S.
Fresenius Kabi USA recalls 0.9% Sodium Chloride Injection and 13 other products nationwide due to lack of sterility assurance, posing potential temporary or reversible health risks.
GE Healthcare Ireland Limited recalls 306,810 vials of Omnipaque (iohexol) injection nationwide due to particulate matter that may cause temporary or reversible health problems.
Viatris recalls Xanax XR 3 mg alprazolam extended-release tablets nationwide due to failed dissolution specifications that may cause temporary or reversible health problems.
FDA seeks public comments on financial transparency and efficiency of prescription drug, biosimilar, and generic drug user fee programs at a public meeting.
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