POSTPONED: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support…
Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of Tydemy™ (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) Due to Out of Specification (OOS) Results
Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451…
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