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- What's New Related to DrugsWant to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
- Frequently requested or proactively posted compliance recordsFrequently requested inspection records of foreign pharmaceutical manufacturing facilities
- FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers - 03/23/2022The FDA Center for Drug Evaluation and Research and the FDA Biomarker Working Group will convene a virtual workshop on March 23-24, 1-3 PM (EST) entitled “Identification of Concepts and Terminology for Multi-Component Biomarkers”. The workshop is intended to develop multi-component biomarker concepts and terminology to identify areas of conceptual
- Drugs@FDA Data FilesDrugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
- Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron VariantThe FDA revised the authorizations for two monoclonal antibody treatments to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible of these treatments.