Public Health Service Act Section 351

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42 U.S. Code § 262 - Regulation of biological products

(6 days ago) WEBThis section of the U.S. Code defines and regulates biological products, such as vaccines, blood, and proteins, that are subject to the Public Health Service …

https://www.law.cornell.edu/uscode/text/42/262

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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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Overview of the Regulatory Framework and FDA's Guidance …

(1 days ago) WEBLearn how FDA regulates biosimilar and interchangeable products under section 351(k) of the Public Health Service Act (PHS Act). Find out the requirements, standards, and …

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

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PUBLIC HEALTH SERVICE ACT-TITLE IIIGENERAL P - GovInfo

(5 days ago) WEBThis web page contains the text of title III of the Public Health Service Act, which authorizes the Secretary of Health and Human Services to conduct and support …

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) WEBThis web page contains the official text of the regulations for licensing biological products under the Public Health Service Act. It covers the general provisions, application …

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) WEBThis web page contains the federal regulations for biologics licensing under section 351 of the Public Health Service Act. It includes the requirements, …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=601.2

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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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eCFR :: 21 CFR Part 600 -- Biological Products: General

(9 days ago) WEBThis web page contains the official text of the federal regulations for biological products, such as vaccines, blood, and gene therapy, as published by the Food and Drug …

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-600

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

(7 days ago) WEBThis section of the U.S. Code authorizes the Secretary to respond to public health emergencies or potential emergencies, such as infectious diseases or bioterrorist …

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

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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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Public Health Service Act as Amended Sections 301-3351

(5 days ago) WEBThis document contains the text for relevant sections of the Public Health Service (PHS) Act, which forms the foundation of HHS’ legal authority for responding to …

https://asprtracie.hhs.gov/technical-resources/resource/1711/public-health-service-act-as-amended-sections-301-3351

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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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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 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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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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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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Background Information: List of Licensed Biological Products with

(8 days ago) WEBThe Purple Book database lists FDA-licensed biological products, including biosimilars and interchangeables, and their reference product exclusivity status. Learn …

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

(5 days ago) WEBLearn how the FDA classifies and regulates cell therapies based on their relative risk and potential benefits. 351 products require clinical trials and approval, while …

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

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