Identification and Investigation of the Intrinsic Receptor Activation Potential and Metabolization of the New Oxo‐Pyridyl Synthetic Cannabinoid Receptor Agonist CH‐FUBBMPDORA

Another Chinese generic ban-evading SCRA, CH-FUBBMPDORA, has emerged. This study reports its first identification in Europe, its analytical characterization (NMR,…

eCTD Submission Standards for eCTD v3.2.2 and Regional M1

eCTD Submission Standards

Cefepime – Injection products

Cefepime – Injection products

Azithromycin – Oral, Injection products

Azithromycin – Oral, Injection products

Ceftazidime – Injection products

Ceftazidime – Injection products; Exceptions to the recognized standard of CLSI M100

Cefuroxime – Injection products

Cefuroxime – Injection products; Exception to the recognized standard of CLSI M100

Levofloxacin Oral, Injection products

Levofloxacin Oral, Injection products

Meropenem – Injection products

Meropenem – Injection products

Moxifloxacin Oral, Injection Products

Moxifloxacin Oral, Injection products: Additional FDA-identified interpretive criteria

Minocycline Oral, Injection products

Minocycline Oral, Injection products