Public Health Service Act Section 351

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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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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 …

https://www.federalregister.gov/documents/1999/10/20/99-27159/biological-products-regulated-under-section-351-of-the-public-health-service-act-implementation-of

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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 …

https://www.fda.gov/media/113820/download

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Guidance for Industry - U.S. Food and Drug Administration

(Just Now) WEBSection 351(a) of the PHS Act. 19 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price 20 Competition and Innovation Act of 2009 (BPCI …

https://www.fda.gov/media/89049/download

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PUBLIC HEALTH SERVICE ACT-TITLE IIIGENERAL P - GovInfo

(5 days ago) WEBPUBLIC HEALTH SERVICE ACT [As Amended Through P.L. 118–66, Enacted July 2, 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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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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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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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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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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Draft Guidance for Industry on Reference Product Exclusivity for

(Just Now) WEBThe BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or …

https://www.federalregister.gov/documents/2014/08/05/2014-18169/draft-guidance-for-industry-on-reference-product-exclusivity-for-biological-products-filed-under

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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 …

https://www.biosimilarsip.com/2020/12/08/fdas-new-draft-guidance-regarding-biosimilarity-and-interchangeability/

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Reference Product Exclusivity for Biological Products Filed Under

(5 days ago) WEBHealth Professionals for Biological Products Filed Under Section 351(a) of the PHS Act.” of first licensure for a reference product under 351(k)(7)(C) of the …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reference-product-exclusivity-biological-products-filed-under-section-351a-phs-act

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42 USC 262: Regulation of biological products

(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, Title IV—National Institutes of Health

(5 days ago) WEBBIOLOGICAL PRODUCT- The term ‘biological product’ has the meaning given such term in section 351 of the Public Health Service Act. HIGH NEED CURE- The term ‘high …

https://www.ncbi.nlm.nih.gov/books/NBK114619/

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Definition of the Term “Biological Product” - Federal Register

(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 …

https://www.federalregister.gov/documents/2020/02/21/2020-03505/definition-of-the-term-biological-product

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42 U.S. Code § 247d - Public health emergencies U.S. Code US …

(7 days ago) WEBthe distribution and administration of vaccines licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) or authorized under section 564 of the …

https://www.law.cornell.edu/uscode/text/42/247d

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How does the U.S. FDA regulate cell therapies? (351 vs 361 Products)

(5 days ago) WEBThese products are called “361 products,” because they are regulated under Section 361 of the Public Health Service (PHS) Act. 351 Products. In contrast, if a cell …

https://bioinformant.com/351-vs-361-products/

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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 …

https://www.fda.gov/drugs/biosimilars/background-information-list-licensed-biological-products-reference-product-exclusivity-and

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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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Biological products regulated under Section 351 of the Public …

(1 days ago) WEBThe Food and Drug Administration (FDA) is proposing to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all …

https://pubmed.ncbi.nlm.nih.gov/10181717/

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