Public Health Service Act

Predicate rules The underlying requirements set in the Federal Food, Drug and Cosmetic Act and the Public Health Service Act and FDA regulations (e.g. GLP), other than Part 11. 

Federal assistance may be provided to state and local authorities in enforcing their quarantine and other health regulations pursuant to section 311 of the Public Health Service Act. (42 U.S.C. 243(a)). In addition, CDC s quarantine regulations authorized Federal intervention in the event of inadequate local control. (Please refer to 42 CFR 70.2, and 21 CFR 1240.30)... 

Publication delays, 24 376 Public Health Service Act, 3 826 Public Health Service Drinking Water Standards, 22 680... 

The Public Health Service Act passes to regulate biological products, the control of communicable... 

The National Childhood Vaccine Injury Act of 1986, Section 2125, Public Health Service Act as codified at 42 U.S.C. 300aa (SuppL), 1987. 

Refer to Sections 7.2.1 and 7.2.2 about the CDER and CBER. It should be understood that small and large molecule drugs are legislated differently the former under the Food, Drug and Cosmetic Act (FDCA) and the latter under the Public Health Service Act (PHSA). 

PHSA Public Health Service Act (United States)... 

The Federal Food, Drug and Cosmetic Act (FFDCA) places the responsibility for establishing the safety and efficacy of human and veterinary drugs and devices and the safety of food and color additives on the sponsor of the regulated product. The Public Health Service Act requires that a sponsor... 

Data and information regarding an electronic product submitted as part of the procedures for establishing, amending, or repealing a standard for such product, described in section 358 of the Public Health Service Act. 

Public Health Service Act—approves most biologies, including recombinant therapeutic proteins... 

G. Other considerations Serono conducted the comparative study to demonstrate that Rebif is clinically superior to Avonex. No other path was available for Serono to have the product licensed by the FDA before mid-2003 because Avonex carried an orphan drug designation based on its superior safety profile over Betaseron, the first interferon beta to be licensed for multiple sclerosis. Based on the results of the Rebif versus Avonex study, the FDA determined that Rebif is clinically superior to Avonex. While recognizing that the safety profile associated with Rebif is not as favorable as the safety profile of Avonex, the FDA has determined that the severity and frequency of such adverse events do not render Rebif unUcensable under Section 35 of the Public Health Service Act. Further, under the orphan drug regulations, if Serono demonstrates that Rebif is superior to Avonex based on efficacy, Serono does not have to show that Rebif is safer than, or as safe as, Avonex. 

Clinton, Jarrett, M.D., Rear Admiral, U.S. Public Health Service, Acting ASD(HA), Office of the Secretary of Defense, April 5, 2001. 

United States Public Health Service Act is passed. 

The degree to which the public health service acts successfully depends on acceptance of official procedures. This requires transparency in presenting the risk assessment undertaken and the risk management provided. A transparent... 

Predicate regulations Federal Food, Drag, and Cosmetic Act, the Public Health Service Act, or any FDA Regulation, with the exception of 21 CFR Part 11. Predicate regulations address the research, production, and control of FDA regulated articles. 

The FDA is responsible for the review and market approval of new drugs, biologies, and medical devices in the United States under the authority of the Federal Food Drug and Cosmetic Act (the Act) and Section 351 of the Public Health Service Act (the PHS Act). The FDA defines premarket review as the examination of data and information in an application as described in Sections 505, 510(k), 513(f), 515, or 520(g) or 520(1) of the Act or Section 351 of the PHS Act. This refers to the premarket review of data and information contained in any Investigational New Drug application (IND), Investigational Device... 

B) preclinical testing involving a drug is designated under section 526 of such Act and before the date on which an application with respect to such drug is submitted under section 505(b) or 507 of such Act or under section 351 of the Public Health Service Act. (2) The term rare disease or condition means... 

G) For purposes of this paragraph, the reviewing division is the division responsible for the review of an application for approval of a drug under this subsection or section 351 of the Public Health Service Act (including all scientific and medical matters, chemistry, manufacturing, and controls). 

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