Public Health Act Section 351
Listing Websites about Public Health Act Section 351
Frequently Asked Questions About Therapeutic Biological …
(9 days ago) WebSection 351 of the Public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic
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Overview of the Regulatory Framework and FDA's …
(1 days ago) Webto be licensed under 351(k) of the Public Health Service Act (PHS Act) based on less than a full complement of product- – An application submitted under section 351(a) of the …
https://www.fda.gov/media/113820/download
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42 U.S. Code § 262 - Regulation of biological products
(6 days ago) Web“If a reference product, as defined in section 351 of the Public Health Service Act (42 U.S.C. 262) (as amended by this Act) has been designated under …
https://www.law.cornell.edu/uscode/text/42/262
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eCFR :: 21 CFR Part 601 -- Licensing
(9 days ago) Web(a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the …
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-601
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Guidance for Industry - U.S. Food and Drug …
(Just Now) Web19 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price 55 7001 through 7003 of the Affordable Care Act). Section 351(k) of the PHS …
https://www.fda.gov/media/89049/download
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Federal Register :: Definition of the Term “Biological …
(5 days ago) WebThe BPCI Act amended the definition of “biological product” in section 351 (i) of the Public Health Service Act (PHS Act) ( 42 U.S.C. 262 (i)) to include a “protein …
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CFR - Code of Federal Regulations Title 21 - Food and …
(Just Now) WebRegistration and listing for human blood and blood products, devices licensed under section 351 of the Public Health Service Act, and licensed biological …
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=807.35
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Biological Products Regulated Under Section 351 of the …
(Just Now) WebTherefore, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and authority delegated to the Commissioner of Food and Drugs, 21 …
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Regulatory Aspects of Vaccine Development, …
(5 days ago) WebSection 351 of the Public Health Service Act (P.L 78-410) requires a manufacturer of biological products to first obtain a license to ship the product (vaccine) in interstate …
https://www.ncbi.nlm.nih.gov/books/NBK236432/
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PUBLIC LAW 117–9—APR. 23, 2021 - Congress.gov
(8 days ago) Webthe Secretary in section 314.3 of title 21, Code of Fed-eral Regulations (or any successor regulations)) of which has been approved in any other application under this section; or …
https://www.congress.gov/117/plaws/publ9/PLAW-117publ9.pdf
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FDA’s New Draft Guidance Regarding Biosimilarity and …
(2 days ago) WebSection 351(i)(2) of the Public Health Service Action (“PHS Act”). An interchangeable product is one that is shown to meet the standards described in section …
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Journal of Tissue Engineering and Regenerative Medicine
(3 days ago) WebThe relevant regulatory framework is included in Sections 351 and 361 of the Public Health Service (PHS) Act of 1944, which define biological products and provide …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6055862/
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Public Health Service Act, Title IV—National Institutes of Health
(5 days ago) WebAppendix B Public Health Service Act, Title IV—National Institutes of Health. Part E—Other Agencies of NIH. BIOLOGICAL PRODUCT- The term ‘biological product’ …
https://www.ncbi.nlm.nih.gov/books/NBK114619/
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Background Information: List of Licensed Biological Products with
(8 days ago) WebSection 351(k)(7) of the Public Health Service (PHS) Act provides for periods of reference product exclusivity, beginning on the date on which the reference …
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42 USC 262: Regulation of biological products - House
(4 days ago) WebSection 105(b) of Pub. L. 99–660 provided that: "Paragraph (1) of section 351(h) of the Public Health Service Act [subsec. (h)(1) of this section] as added by subsection (a) …
https://uscode.house.gov/view.xhtml?req=granuleid:USC-1994-title42-section262&num=0&edition=1994
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What are 351(A) & 351(K)? - Freyr Solutions
(8 days ago) Web351(a) is the traditional pathway for approval of biologics and innovator biologics under the Public Health Service (PHS) act. Under section 351(a), the submitted application must …
https://www.freyrsolutions.com/what-is-351a-351k
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Public Health Service Act as Amended Sections 301-3351
(5 days ago) WebU.S. Congress. (2013). Public Health Service Act, as Amended, Sections 301-3351. U.S. Government Publishing Office. This document contains the text for …
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PUBLIC HEALTH SERVICE ACT-TITLE IIIGENERAL P - GovInfo
(5 days ago) WebPUBLIC HEALTH SERVICE ACT [As Amended Through P.L. 118–42, Enacted March 9, 2024] øCurrency: This publication is a compilation of the text of title III of Chapter 373 of …
https://www.govinfo.gov/content/pkg/COMPS-8773/pdf/COMPS-8773.pdf
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Public Health Service Act - an overview ScienceDirect Topics
(9 days ago) WebThe contrasting regulatory pathways for PHS Act Section 361 and 351 products create a dichotomy between FDA approaches to the oversight of …
https://www.sciencedirect.com/topics/computer-science/public-health-service-act
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“Deemed to be a License” Provision of the BPCI Act FDA
(5 days ago) WebOn March 23, 2020, the BPCI Act requires that an approved marketing application for a “biological product” under section 505 of the FD&C Act shall be deemed to be a license …
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45 U.S. Code § 351 - Definitions - LII / Legal Information Institute
(6 days ago) Web§ 351; Quick search by citation: Title. Section. Go! 45 U.S. Code § 351 - Definitions The amendments made by sections 1, 1, and 1(d)(1) of this Act [amending this section and …
https://www.law.cornell.edu/uscode/text/45/351
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Public Health Service Act (1944) - The Children's Vaccine Initiative
(5 days ago) WebE Public Health Service Act (1944) Public Laws—Ch. 373—July 1, 1944 Part F—Biological Products Regulation of Biological Products. The Service may prepare …
https://www.ncbi.nlm.nih.gov/books/NBK236414/
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