The Knowledge Shelf

FDA Rationale for Recognition Decision: Isavuconazonium sulfate

FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria

Get to know FDA’s drug development and approval process — ensuring that drugs work and that the benefits outweigh their known risks.

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.

Beaver Street Fisheries, LLC of Jacksonville, FL is voluntarily recalling a limited quantity of Great Value Frozen Raw Shrimp EZ-Peel & Deveined Tail-On 21-25 Per lb as a precautionary measure per the recommended action stated in an FDA advisory statement dated 08/19/25 regarding Cesium-137 (Cs-137)

BRENHAM, Texas, August 22, 2025 – Blue Bell Ice Cream is voluntarily recalling a limited quantity of Moo-llennium Crunch Ice Cream half gallon packaged in a Chocolate Chip Cookie Dough carton produced in its Brenham, Texas, plant because of undeclared almond, walnut, and pecan. The recalled product

Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis due to risk of resistance during device withdrawal

The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for the following therapeutic areas: gastrointestinal, lung, and head and neck cancers; neuro-oncology, rare cancers, pediatric

Office Renaming

Drug Shortages Homepage

CDER Guidance Agenda