PDUFA VII Commitment: An Assessment of the Sentinel System (2022 to 2024)

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

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Removes Recommended Pause in Use and Approves Required Updated Labeling: FDA Safety Communication

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.

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/08/2025
Short Title (70 char) Olympia Pharmaceuticals. Orlando, FL. 483 issued 08/08/2025
FEI Number 3009724085
Firm Name Olympia Pharmaceuticals
Record Type 483
State FL
Establishment Type Outsourcing Facili

FDA report demonstrating greater competition among generic drug makers can lead to lower generic drug prices.

The Food and Drug Administration is advising consumers not to purchase or use ZoomMax, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.