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. […]

Delivery Method: VIA Electronic Mail Reference #: 320-26-04 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Veblen Liang Recipient Title General Manager Foshan Yiying Hygiene Products […]

Product: Drugs Recipient: www.usmedschoice.com United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States FROM: The United States Food and Drug Administration RE: […]

Delivery Method: VIA UPS Reference #: 320-26-03 Product: Drugs Recipient: Recipient Name Mr. Walter C. Johnsen Recipient Title CEO Acme United Corporation 1 Waterview Drive Suite […]