English    Español (Spanish)    CDC COVID-19 Communication Toolkit: For Migrants, Refugees, and Other Limited-English-Proficient Populations in various languages 미식품의약국 (FDA)으로부터 코비드-19 (COVID-19) 백신에 대하여 더 많이 배우십시 (Learn […]

Docket Number: FDA-2023-D-4719 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This FDA guidance provides information to sponsors and nonclinical laboratories regarding the […]

Docket Number: FDA-2019-D-1264 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Over the past few decades, FDA […]

1995.  OxyContin (oxycodone controlled-release) approved; first formulation of oxycodone that allowed dosing every 12 hours instead of every 4 to 6 hours.   1998.  Actiq (fentanyl) […]

For Immediate Release: April 03, 2024 Today, the U.S. Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with […]

Minimum InhibitoryConcentrations (mcg/mL) Disk Diffusiona(zone diameters in mm)  Pathogenb S I R S I R Staphylococcus aureus(includes methicillinresistant isolates) ≤ 2 4 ≥ 8 ≥ 16 […]

Delivery Method: VIA Electronic Mail Reference #: 24-HAFE4-WLCOL-05 Product: DrugsFood & Beverages Recipient: Recipient Name Dr. Howard J. Loff, M.D. Recipient Title Owner and CEO Golden […]

Delivery Method: Via Email Product: DrugsFood & Beverages Recipient: Recipient Name Dr. Howard J. Loff, M.D. Recipient Title Owner and CEO Golden Lab LLC 2375 Saint […]

For Immediate Release: April 02, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]