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February 22, 2024

Biosimilars Guidances

Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try searching for […]
February 22, 2024

Generics Guidances

Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try searching for […]
February 22, 2024

Novel Drug Approvals for 2024

Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new drugs […]
February 22, 2024

Notice of Updates

Amikacin Injection FDA does not recognize MI00 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosa Antibacterial 4/21/2023 Amoxicillin and clavulanate Oral FDA does not […]
February 22, 2024

Cefepime and Enmetazobactam Injection

Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion b(zone diameter in mm) Pathogen S SDD I R S SDD I R Enterobacterales a,c ≤8/8 – – ≥16/8 ≥21 – – […]
February 22, 2024

Drug Trials Snapshots: JESDUVROQ

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
February 22, 2024

FDA and Kratom

FDA recognizes that there is much that is not known scientifically about kratom. Although there are published animal studies with kratom extracts containing mitragynine or 7-OH-mitragynine, […]
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