Notice 8 May 2025 regulatory compliance, public comment, pharmaceuticals, fda, drug approval, oncology

💊FDA Oncologic Drugs Advisory Committee Meeting Notice

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

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Notice 5 May 2025 regulatory compliance, healthcare, fda, user fees, generic drugs

💊FDA's Generic Drug User Fee Program Information Collection Overview

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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Notice 5 May 2025 compliance, healthcare, regulations, fda, human cells, biotechnology, tissues

🧬FDA Draft Guidance on Disease Risks in Human Cells, Tissues

The Food and Drug Administration (FDA or the Agency) is withdrawing two final guidances entitled "Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" and "Recommendations to Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" and reissuing them as draft guidances.

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Notice 2 May 2025 compliance, regulation, fda, bottled water, microbiological testing, coliform

💧FDA Microbiological Testing Regulations for Bottled Water

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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Notice 1 May 2025 regulatory compliance, fda, food safety, medicated feed, animal feed

📋Medicated Feed Mill Licensing Information Collection Notice

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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Notice 1 May 2025 compliance, reporting, fda, regulatory requirements, antimicrobial resistance, animal drugs

📋FDA Notice on Antimicrobial Animal Drug Sales Reporting Requirements

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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Notice 1 May 2025 compliance, regulations, safety, fda, manufacturing, animal food, food additives

🐶FDA Proposes New Regulations on Animal Food Additives

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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Notice 1 May 2025 compliance, regulations, international trade, business operations, fda, human food program, food export

🍽️FDA Proposed Collection for Exporting Human Food Products

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with export lists for products regulated by the Human Food Program (HFP).

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Notice 1 May 2025 regulatory compliance, fda, health, medical devices, influenza

🧪FDA Notice on Reagents for Detection of Specific Novel Influenza A Viruses

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with Agency guidance on reagents for detection of specific novel influenza A viruses.

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Notice 1 May 2025 regulatory compliance, business operations, fda, drug quality, outsourcing facilities, compounding

💊FDA Notice on Challenges for Compounding Outsourcing Facilities

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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