Citalopram (marketed as Celexa) is included in the class of drugs called selective serotonin reuptake inhibitors (SSRIs). This class of drugs is used to treat depression, anxiety, and other mood […]

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER July 29, 2025 RE: 711274 Dear AlzClipp: […]

CDER’s Office of Prescription Drug Promotion (OPDP)’s four-person research team investigates issues in direct-to-consumer and health care provider-directed prescription drug promotional communications. The team uses methodologies […]

Developing New Drugs American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this […]

FDA has completed their review of the rationale document titled, “Isavuconazole Breakpoints for Aspergillus fumigatus” submitted by the Clinical and Laboratory Standards Institute (CLSI) to the […]

Guidance documents represent the Agency’s current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the […]

On This Page Date: September 24, 2025 Time: 9:00 a.m. – 12:00 p.m. ET The Food and Drug Administration (FDA) is holding a hybrid public meeting […]