US FDA

FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area.

Jubilant HollisterStier General Partnership – 6/14/2024. Country: Canada. Record Type: 483

Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs

Cartersville, GA – 7/30/2025 – Doehler Dry Ingredient Solutions, LLC is recalling Member’s Mark Freeze Dried Fruit Variety Pack 15 count boxes, UPC 1 93968 50900 2 due to contamination with Listeria monocytogenes. Listeria monocytogenes, an organism which can cause serious and sometimes fatal infect

ISTAND supports innovative, science-driven approaches that improve drug development and regulatory decision-making, ultimately helping to make therapies available to address patients’ unmet needs.

The Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program is designed to expand DDT types by encouraging development of DDTs that are out of scope for existing DDT qualification programs but may still be beneficial for drug development.

Digital Health Technologies (DHTs) for Drug Development

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

FDA’s Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) recently launched a pilot program on Novel Excipient Review. The pilot program offers a new pathway for drug manufacturers to obtain FDA review of certain novel excipients (inactive ingredients)

The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or biologics development.

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 03/27/2025
Short Title (70 char) Apollo Care LLC. Columbia, MO. 483 issued 03/27/2025
FEI Number 3013927023
Firm Name Apollo Care LLC
Record Type 483
State MO
Establishment Type Outsourcing Facility

MODESTO, CA, July 29, 2025 – High Noon is recalling two production lots of High Noon Beach Variety packs (12-pack/12 fluid ounce cans). Some of these packs contain cans that are filled with High Noon vodka seltzer alcohol and are mislabeled as CELSIUS® ASTRO VIBE™ Energy Drink, Sparkling Blue Razz E