Pharma & Drug Safety

FDA Guidance: Cancer Trial Eligibility Criteria

The FDA has issued new guidance regarding eligibility criteria for cancer clinical trials, specifically addressing washout periods and concomitant medications. This guidance aims to help sponsors and IRBs develop trials that are inclusive while ensuring participant safety. Comments on the guidance can be submitted at any time.

FDA Final Guidance on Bioresearch Monitoring Inspections

The FDA has issued final guidance detailing processes and practices for Bioresearch Monitoring inspections, as mandated by the Food and Drug Omnibus Reform Act of 2022. This guidance outlines record and information requirements, communication best practices, and inspection conduct for regulated entities.

Medline Industries Recalls Electrophysiology and Ultrasound Catheters

Medline Industries is expanding a recall of reprocessed electrophysiology and ultrasound catheters due to potential residual particulates. The FDA has classified this as the most serious type of recall, as the devices could cause serious injury or death. Affected customers are instructed to return or destroy the product.

FDA Identifies Infusion Pump Software Correction as Most Serious Recall

The FDA has identified a software correction for the Fresenius Kabi Ivenix Large Volume Pump as its most serious type of recall, indicating a potential risk of serious injury or death. Affected healthcare providers are urged to update the pump software to version 5.10.2 as soon as possible and implement temporary risk mitigation measures.

Modern Warrior Recalls Dietary Supplement Due to Undeclared Ingredients

Modern Warrior is voluntarily recalling its 'Modern Warrior Ready' dietary supplement due to the presence of undeclared tianeptine, 1,4-DMAA, and aniracetam. The FDA is highlighting the serious health risks associated with these ingredients, including potential life-threatening cardiovascular events and suicidal ideation.

Green Lumber Recalls Dietary Supplements for Undeclared Tadalafil

Green Lumber Holding, LLC is updating a recall for counterfeit dietary supplements falsely marketed as Green Lumber. The counterfeit products contain undeclared Tadalafil, a prescription drug, posing potential health risks. Consumers are advised to check lot numbers and discontinue use of affected products.

FDA Recall of Silintan Capsules for Undeclared Meloxicam

Anthony Trinh, 123Herbals LLC is voluntarily recalling all lots of Silintan capsules due to the presence of undeclared meloxicam, an approved NSAID. The FDA analysis found the product to be an unapproved new drug, posing risks of serious health events.

Gold Star Distribution Recalls FDA Products Due to Contamination

Gold Star Distribution, Inc. is recalling all FDA-regulated products held at its facility due to rodent, avian, and insect contamination and insanitary conditions. The FDA determined the facility operated under insanitary conditions, posing a significant risk of product contamination and potential illness from microorganisms like Salmonella.

Navafresh Recalls Rheumacare Capsules Due to Elevated Lead Levels

Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Rheumacare Capsules due to elevated lead levels found by the FDA. The recall impacts consumers nationwide and is being conducted with the FDA's knowledge.

MHRA Advertising Investigations and Decisions

The MHRA has published decisions following investigations into advertising complaints for licensed medicines, specifically concerning weight loss treatments. Ten decisions were made in February 2026 regarding websites and services that highlighted medicinal treatments for weight loss.