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

🧬FDA Draft Guidance on Disease Risks in Human Cells, Tissues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 5 May 2025 regulatory compliance, user fees, fda, healthcare, 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 2 May 2025 fda, regulation, bottled water, microbiological testing, compliance, 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 fda, regulatory requirements, compliance, antimicrobial resistance, reporting, 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 fda, medicated feed, food safety, regulatory compliance, 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 fda, compliance, manufacturing, animal food, regulations, food additives, safety

🐶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 fda, human food program, compliance, business operations, regulations, international trade, 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 fda, medical devices, influenza, regulatory compliance, health

🧪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 fda, compounding, drug quality, business operations, regulatory compliance, outsourcing facilities

💊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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Notice 1 May 2025 fda, importing, food industry, food safety, regulatory compliance

📦FDA Notice on Foreign Supplier Verification Programs for Food Importers

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 of FDA's Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.

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