Individual Case Safety Reports
This web page is dedicated to the health and regulatory data standard: Individual Case Safety Report
Compounding Quality Center of Excellence | Instructor-Led Trainings
The Compounding Quality Center of Excellence’s free in-person training programs target outsourcing facility staff and offer continuing education credits. The…
Drug Compliance Programs
FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the…
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