Public Health Service Act 351
Listing Websites about Public Health Service Act 351
Frequently Asked Questions About Therapeutic Biological Products
(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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Biological Products Regulated Under Section 351 of the Public …
(Just Now) WEBThe Food and Drug Administration (FDA) is amending the biologics regulations to eliminate references to establishment licenses and product licenses for all …
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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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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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PUBLIC LAW 117–9—APR. 23, 2021 - Congress.gov
(8 days ago) WEBPUBLIC LAW 117–9—APR. 23, 2021 135 STAT. 257 ‘‘(B) a biological product, no active ingredient of which has been approved in any other application under section 351 of the …
https://www.congress.gov/117/plaws/publ9/PLAW-117publ9.pdf
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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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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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Federal Register :: Definition of the Term “Biological Product”
(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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Biological Products Regulated Under Section 351 of the Public …
(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, …
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eCFR :: 21 CFR Part 600 -- Biological Products: General
(9 days ago) WEB(1) An applicant of a biological product, other than blood or blood components for transfusion, which is licensed under section 351 of the Public Health Service Act, and …
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-600
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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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Public Health Service Act (1944) - The Children's Vaccine Initiative
(5 days ago) WEBPublic Laws—Ch. 373—July 1, 1944 Part F—Biological Products Regulation of Biological Products. Sale, barter or exchange in D.C., etc. Sec. 351. (a) No person shall sell, …
https://www.ncbi.nlm.nih.gov/books/NBK236414/
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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, 351(k) application is a biologics license application …
https://www.freyrsolutions.com/what-is-351a-351k
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Regulatory Aspects of Vaccine Development, Manufacture, and
(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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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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Biological products regulated under Section 351 of the Public …
(1 days ago) WEBThe Food and Drug Administration (FDA) is announcing a public workshop to present issues related to the agency's proposed rule entitled "Biological Products …
https://pubmed.ncbi.nlm.nih.gov/10182565/
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