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FDA Variance Approval Letter to DePaul University

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to DePaul University's Idea Realization Laboratory. This document signifies approval for a specific variance related to medical device development or testing.

Routine Guidance Medical Devices
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FDA Variance Request from Laina Callow - Comment Period Closed

The Food and Drug Administration (FDA) has closed the comment period for a variance request submitted by Laina Callow. The application, authored by CDRH, was available for public comment on regulations.gov.

Routine Consultation Healthcare
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FDA Variance Application from Axion Laser

The Food and Drug Administration (FDA) has posted a variance application from Axion Laser. This document is available for review on the FDA's regulations.gov portal.

Routine Guidance Medical Devices
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FDA Final Response Letter to Athyna Pharma LLC

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a final response letter to Athyna Pharma LLC. This document provides specific feedback and guidance related to the company's pharmaceutical development or regulatory submissions.

Routine Guidance Pharmaceuticals
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FDA Acknowledgment Letter to Ingram Planetarium

The Food and Drug Administration (FDA) has issued an acknowledgment letter to Ingram Planetarium regarding a submission. The letter, dated March 26, 2026, confirms receipt of documentation from the Center for Devices and Radiological Health (CDRH). No specific details about the submission's content or regulatory implications are provided.

Routine Notice Healthcare
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DePaul University Variance Application

The FDA has posted a variance application submitted by DePaul University's Idea Realization Laboratory. The document is available for review on the Regs.gov platform. No specific compliance actions or deadlines are indicated for other entities.

Routine Notice Healthcare
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FDA CDRH Variance Approval Letter to Axion Laser

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to Axion Laser. This document grants a specific variance, indicating an approved deviation from standard regulatory requirements for a particular product or process.

Routine Guidance Medical Devices
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Meloxicam Pharmaceutical Composition and Application

The USPTO has published a patent application (US20260083748A1) for a pharmaceutical composition containing meloxicam, a composite solvent, and an acidic pH regulator. The assignee is Beijing Tide Pharmaceutical Co., Ltd. This application details a preparation method and its application, focusing on a formulation that avoids organic solvents for increased safety and reduced environmental impact.

Routine Guidance Pharmaceuticals
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Antimicrobial Compositions Patent Application

The USPTO has published a patent application (US20260083126A1) for antimicrobial compositions containing organosulfur compounds. The application, filed on September 8, 2023, describes compounds useful for treating microbial infections and for cleaning, disinfecting, or agricultural use.

Routine Notice Pharmaceuticals
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Chemical Compound with Triazine Group and Production Method

The USPTO has published a patent application (US20260085087A1) for a chemical compound comprising a triazine group and its production method. The application relates to novel nucleotides and oligonucleotides with modified phosphate groups, potentially useful in diagnostics, gene therapy, and treating bacterial and viral diseases, including COVID-19.

Routine Notice Pharmaceuticals

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