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 […]

Delivery Method: VIA UPS Reference #: 320-25-117 Product: Drugs Recipient: Recipient Name Mr. Guo Guorong Recipient Title Chairman & General Manager Guangxi Yulin Pharmaceutical Group Co. […]