Exceptions or additions to the recognized standards   Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Staphylococcus aureus ≤ 4 […]

Docket Number: FDA-2013-D-0446 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research FDA is posting this document to provide advance notice to the public. […]

Docket Number: FDA-2022-D-1385 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health […]

Podcast Thank you for joining us for another episode of the Guidance Recap Podcast. My name is Kylie Haskins, and I am today’s host. In this […]

Best Practices for Communication Between IND Sponsors and FDA During Drug Development Final Guidance  Updated guidance on best practices for communication between IND sponsors and FDA […]

  Online Advisory Letter Reference #715639 September 8, 2025 MOLOOCO dba [email protected]: DoubleNano Advanced Lung Detox Relief Patch To whom it may concern: This letter is […]

FDA is requiring labeling changes to strengthen the warnings that tranexamic acid injection should be administered only intravenously (into the vein). Tranexamic acid injection products are […]