FDA Drug Safety Communication: FDA modifies monitoring for neutropenia associated with schizophrenia medicine clozapine; approves new shared REMS program for all clozapine medicines

[09-15-2015] The U.S. Food and Drug Administration (FDA) is making changes to the requirements for monitoring, prescribing, dispensing, and receiving…

Ascent Consumer Products Inc. Issues Voluntary Nationwide Recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System Due to Microbial Contamination

02/25/2025 Melville, NY. Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash…

Bobbie opens fulfillment center in Georgia

The infant formula maker’s addition expands the company’s Southeast reach, according to VP of Supply Chain Dominic Mills.

Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act

Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments…

Leveraging supply chain data remains a headache

Manifest 2025 speakers were split on the benefits of shared standards, but greater transparency among stakeholders could offer upside.

Trucking executives answer questions on upcoming freight classification changes

Leaders at Estes Express Lines, XPO and Old Dominion Freight Line recently discussed the NMFC shift looming this summer.

DHL exec outlines 5 supply chain ‘megatrends’

Trade shifts and emerging technologies are creating new challenges and opportunities, said Patrick Kelleher, DHL Supply Chain’s North America CEO.

Frequently Asked Questions | Clozapine REMS Modification

The Clozapine REMS is a shared system REMS for all approved clozapine products.

Information on Clozapine

Clozapine (marketed as Clozaril, Fazaclo ODT, Versacloz and generics) is an antipsychotic medicine used to treat schizophrenia in patients whose…

More ‘shrinkflation’? How Trump tariffs could reverberate through the food industry

Food and beverage companies sensitive to inflation-wary consumers are unlikely to immediately raise prices, experts say, but could respond by changing…