Public Health Act Section 351
Listing Websites about Public Health Act Section 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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Overview of the Regulatory Framework and FDA's Guidance …
(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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eCFR :: 21 CFR 601.2 -- Applications for biologics licenses; …
(3 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/subpart-A/section-601.2
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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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CFR - Code of Federal Regulations Title 21 - Food and Drug …
(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 …
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=601.2
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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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CFR - Code of Federal Regulations Title 21 - Food and Drug …
(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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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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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 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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Public Law 117–8 117th Congress An Act
(8 days ago) WEBSubpart 1 of part F of title III of the Public Health Service Act (42 U.S.C. 262 et seq.) is amended by adding at the end the following: ‘‘SEC. 352A. EDUCATION ON …
https://www.congress.gov/117/plaws/publ8/PLAW-117publ8.pdf
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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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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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Guidance for Industry - U.S. Food and Drug Administration
(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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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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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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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 …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6055862/
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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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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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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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Fiscal Year (FY) 2025 Quality Improvement Fund - Health …
(2 days ago) WEBThis notice announces the opportunity for health centers funded by HRSA under section 330 of the Public Health Service Act to apply for funding under Fiscal …
https://www.hrsa.gov/grants/find-funding/HRSA-25-005
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Guidance for Industry - U.S. Food and Drug Administration
(1 days ago) WEBsection 505 or under section 351 of the Public Health Service Act for such drug.” 11. The first sentence of section 502(a)(1) of the FD&C Act provides that a drug or device is …
https://www.fda.gov/media/133620/download
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H.R.7888 - Reforming Intelligence and Securing America Act
(5 days ago) WEB(a) Sense of congress on the targeted collection of United States person information.—It is the sense of Congress that, as proscribed in section 702(b)(2), …
https://www.congress.gov/bill/118th-congress/house-bill/7888/text
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Sierra Club Statement on EPA Action to Protect Public Health for
(1 days ago) WEBWashington, DC – This week, the U.S. Environmental Protection Agency (EPA) announced that it has denied a petition to remove stationary combustion turbines …
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Federal Register :: Patient Protection and Affordable Care Act, HHS
(Just Now) WEBSection 1331 of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152, enacted …
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Reference Product Exclusivity for Biological Products Filed Under
(5 days ago) WEBHealth Professionals Biological Products Filed Under Section 351(a) of the PHS Act date of first licensure for a reference product under 351(k)(7)(C) of the …
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