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anthony-trinh,-123herbals-llc-(123herbals.com)-issues-nationwide-recall-of-silintan-capsules-due-to-the-presence-of-undeclared-meloxicam Drug Test
  • January 9, 2026

Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam

Rosemead, CA, ANTHONY TRINH, 123herbals LLC is voluntarily recalling all lots of Silintan capsules to the consumer level. FDA analysis…
final-report-fda-ema-pilot-program-for-the-parallel-assessment-of-quality-by-design-elements-of-marketing-applications Drug Test
  • January 9, 2026

Final Report FDA-EMA pilot program for the parallel assessment of quality-by-design elements of marketing applications

Final Report from the FDA-EMA pilot program for the parallel assessment of quality-by-design elements of marketing applications
human-drug-imports Drug Test
  • January 9, 2026

Human Drug Imports

Human drug import information including PLAIR, safe importation action plan, and personal importation policy.
importing-liquid-cough-and-cold-medicine-from-india Drug Test
  • January 9, 2026

Importing Liquid Cough and Cold Medicine from India

FDA is aware of news reports of devastating, ongoing diethylene glycol (DEG) and ethylene glycol (EG) contamination in children’s cough…
use-of-bayesian-methodology-in-clinical-trials-of-drug-and-biological-products Drug Test
  • January 9, 2026

Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products

This draft guidance provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics…
fda-approves-prescription-nasal-spray-to-reverse-opioid-overdose Drug Test
  • January 8, 2026

FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose

The U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known…
fda-approves-first-over-the-counter-naloxone-nasal-spray Drug Test
  • January 8, 2026

FDA Approves First Over-the-Counter Naloxone Nasal Spray

The U.S. Food and Drug Administration approved the first naloxone nasal spray product available without a prescription.
fda/center-for-research-on-complex-generics-(crcg)-workshop-on-visionary-standards:-advancing-science-and-regulation-in-generic-ophthalmic-products-–-11/19/2025 Drug Test
  • January 8, 2026

FDA/Center for Research on Complex Generics (CRCG) Workshop on Visionary Standards: Advancing Science and Regulation in Generic Ophthalmic Products – 11/19/2025

This 2-day hybrid workshop will explore the evolving landscape of generic ophthalmic drug products, where increasing formulation complexity and innovative…
Drug Test
  • January 7, 2026

A Robust Multistep Digestion Method for Microplastics Detection in Human Tissue by MicroRaman Analysis

A unified digestion protocol for human biological samples has been developed for microplastics analysis by microRaman Spectroscopy. ABSTRACT The presence…
fda-information-session-on-generic-drug-research-needs-&-opportunities-for-fy-2026-–-01/21/2026 Drug Test
  • January 7, 2026

FDA Information Session on Generic Drug Research Needs & Opportunities for FY 2026 – 01/21/2026

FDA is hosting a virtual Information Session on Generic Drug Research Needs & Opportunities for fiscal year (FY) 2026 on…