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Failure to Register and List
Conducting Remote Regulatory Assessments Questions and Answers
Conducting Remote Regulatory Assessments Questions and Answers Guidance for Industry
January – March 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
January – March 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System…
OMUFA Performance Reports
Over-the-Counter Monograph Drug User Fee annual performance reports to Congress
SARMs, Metabolic Modulators and Growth Hormone Secretagogues in Suspected Illegal Medicines, Bought as Sport Performance Enhancers: A Retro‐ and Prospective Study Within the GEON
Data on the presence of illegal products containing SARMs, metabolic modulators and GHS was collected by 13 countries, member of…
Development of an Optimized Extraction Method to Recover Drug Material From Used Test Strips for Comprehensive Drug Checking
This study aims to develop an optimized method for the extraction of compounds from used test strips for additional mass…
Monitoring Community Use of Benzodiazepines Through Wastewater‐Based Epidemiology
Validated LC–MS/MS method for 26 prescription BZDs was applied to influent wastewater in Belgium, Latvia, Lithuania and Romania, revealing spatial…
FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system)
The antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or…
Post-Warning Letter Meetings Under GDUFA
Post-Warning Letter Meetings Under GDUFA
2025 Meeting Materials, Psychopharmacologic Drugs Advisory Committee
2025 Meeting Materials, Psychopharmacologic Drugs Advisory Committee