351 Public Health Service Act H
Listing Websites about 351 Public Health Service Act H
42 U.S. Code § 262 - Regulation of biological products
(6 days ago) WEBDuring the period beginning on the date of enactment of this Act [Mar. 23, 2010] and ending on October 1, 2010, the Secretary [of Health and Human Services] shall collect and evaluate data regarding the costs of reviewing applications for biological …
https://www.law.cornell.edu/uscode/text/42/262
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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 [former subsec. (h)(1) of this section] as added by …
https://uscode.house.gov/view.xhtml?req=granuleid:USC-2007-title42-section262&num=0&edition=2007
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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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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- specific preclinical and clinical data à abbreviated …
https://www.fda.gov/media/113820/download
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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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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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The Biologics License Application (BLA) - Food and Drug Law …
(5 days ago) WEBFocus: Section 351(a) BLA •Public Health Service Act describes two approval pathways: –Section 351(a): the full BLA –Section 351(k): the biosimilar BLA 6 under section 351 …
https://fdli.org/wp-content/uploads/2020/10/Hegreness-Matthew.pdf
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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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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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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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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 …
(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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CFR - Code of Federal Regulations Title 21 - Food and Drug …
(7 days ago) WEBThe information on this page is current as of Dec 22, 2023. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations …
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=3.2
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FDA’s Overview of the Regulatory Guidance for the …
(Just Now) WEBbe licensed under 351(k) of the Public Health Service Act (PHS submitted under section 351(k) of the PHS Act. Note: A biological product, in a 351(k) application, may
https://www.fda.gov/media/90496/download
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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 95 A biological product submitted for licensure under section 351(a) of the PHS …
https://www.fda.gov/media/89049/download
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TH ST CONGRESS SESSION H. R. 736
(1 days ago) WEB21 health counseling services with respect to a vaccine li-22 censed under section 351 of the Public Health Service Act 23 (42 U.S.C. 262) for the prevention, mitigation, or treat …
https://www.congress.gov/117/bills/hr736/BILLS-117hr736ih.pdf
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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 (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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U.S.C. Title 42 - THE PUBLIC HEALTH AND WELFARE - GovInfo
(1 days ago) WEB42 U.S.C. United States Code, 2013 Edition Title 42 - THE PUBLIC HEALTH AND WELFARE CHAPTER 6A - PUBLIC HEALTH SERVICE From the U.S. Government …
https://www.govinfo.gov/content/pkg/USCODE-2013-title42/html/USCODE-2013-title42-chap6A.htm
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Public Health Service Act - Wikipedia
(5 days ago) WEBPandemic and All-Hazards Preparedness Reauthorization Act of 2013. The Public Health Service Act is a United States federal law enacted in 1944. [2] The full act is codified in …
https://en.wikipedia.org/wiki/Public_Health_Service_Act
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Title II of the Drug Quality and Security Act FDA
(1 days ago) WEBproduct under section 351 of the Public Health Service Act that meets the definition of a device under section 201(h). ``(25) Transaction history.--The term `transaction history'
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H.R.8520 - 118th Congress (2023-2024): To amend the Public …
(Just Now) WEBSummary of H.R.8520 - 118th Congress (2023-2024): To amend the Public Health Service Act to require the Secretary of Health and Human Services, acting …
https://www.congress.gov/bill/118th-congress/house-bill/8520
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