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

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

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

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

CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product…

FDA is evaluating the root cause of benzene contamination in certain drugs and alerting drug manufacturers to the risk of…

Frequently requested or proactively posted drug-specific and other records

FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate…

Rogue online pharmacies offer potentially dangerous prescription drugs to U.S. consumers. FDA has issued warning letters informing the website operators…