🐾FDA Guidance on Type VII Veterinary Master Files for R&D Released
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #260 entitled "Type VII Veterinary Master File for Research and Development and Risk Reviews." This draft guidance, when finalized, will describe FDA's current thinking regarding the use of Type VII Veterinary Master Files (Type VII VMFs). Type VII VMFs are appropriate for research and development of animal cells, tissues, and cell- and tissue-based products (ACTPs), gene therapies, and heritable intentional genomic alterations (IGAs) in animals.
Learn More🌪️North Carolina Disaster Declaration
This is an amendment of the Presidential declaration of a major disaster for the State of North Carolina (FEMA-4827-DR), dated September 28, 2024. Incident: Tropical Storm Helene.
Learn More📦USPS Notice on New Shipping Service Agreements and Implications
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Learn More📦Notice on USPS Product Change for Priority Mail and Shipping Services
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Learn More⚕️FDA Announces Draft Guidance for In Vitro Diagnostic Devices
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency." The draft guidance describes general recommendations for the validation of in vitro diagnostic devices (IVDs) for emerging pathogens during an applicable declaration of public health emergency. This guidance and the associated template include the recommendations that apply to test data and information submitted in a pre-Emergency Use Authorization (EUA), an EUA request, or to a test offered as described in an applicable enforcement discretion policy. This draft guidance is not final nor is it for implementation at this time.
Learn More📦USPS Priority Mail & Ground Advantage Contract Changes Notice
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
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