Advancing Real-World Evidence Program

Infusion pumps released with incorrect software can experience unexpected performance problems, including issues with essential functions and risk measures.

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

Guidance documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.

This Table provides the current number of active CDER Drug Development Tool (DDT) Qualification projects overall and by Program (DDT- Animal Model Qualification Program, DDT- Biomarker Qualification Program, DDT- Clinical Outcomes Assessment [COA] Qualification Program). Numbers are also provided by

The Food and Drug Administration is advising consumers not to purchase or use X3 500K GOLD EDITION, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/18/2025
Short Title (70 char) Petscript Inc. Paris, TX. 483 issued 09/18/2025
FEI Number 3010282564
Firm Name Petscript Inc
Record Type 483
State TX
Establishment Type Producer of Sterile and Non-sterile