Laboratory Manual of Quality Policies (ISO 17025 Requirements)

The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors

The Genetic Metabolic Diseases Advisory Committee (GeMDAC) advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs and biologic products for human use and as required.

Creating a medication tailored to the needs of an individual patient. FDA answers the “what” and “why” of compounding. From consumers to health care professionals, there are many questions about compounding. FDA works to answer questions related to the meaning, intent and requirements of compounding

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/05/2025
Short Title (70 char) FarmaKeio Outsourcing LLC. Southlake, TX. 483 issued 09/05/2025
FEI Number 3014982757
Firm Name FarmaKeio Outsourcing LLC
Record Type 483
State TX
Establishment Type Outsourcing

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet