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Establishment license application

Establishment Inspection Report Establishment License Application enzyme linked immunosorbent assay European Medicines Agency Environmental Protection Agency European Public Assessment Report end of production cell bank erythropoietin... [Pg.437]

Application and approval process NDA (New Drug Application) PLA (Product License Application) ELA (Establishment License Application) BLA (Biologic License Application)... [Pg.16]

The BLA was established pursuant to the Food and Drug Administration Modernization Act of 1997, consolidating a prior requirement for two applications a Product License Application and an Establishment License Application. The final implementing rule reduced the amount of information a manufacturer is required to file in its BLA application and shifted responsibility to the plant inspection process to ensure that manufacturers complied with cGMP standards. [Pg.36]

Product License Applications and Establishment License Applications, March 10,1999. [Pg.62]

Outlined licensing requirements for biologies—for both product (product licensing application, or PLA) and establishment where the product was manufactured (establishment licensing application, or ELA)... [Pg.38]

All blood establishments are required to submit information describing their proposed computer systems along with their Establishment License Application (ELA). Moreover, any important proposed change to a computer system or database is also reportable as a supplement to the original ELA. [Pg.925]

For all other biological products, sponsors must submit two applications, an establishment license application (ELA) and a product license application (PLA). Both submission processes (BLA or ELA/PLA) may require nonclinical and clinical data, chemical and biological information, and information on the product manufacturing process and facility. Ultimately, the single-application... [Pg.183]

PLA/ELA Product License Application/Establishment License Application... [Pg.540]

These data exclude product license applications/establishment license applications reviewed by CBER (most of which would appear in the most recent period). [Pg.162]

CBER —Center for Biologies Evaluation and ELA —establishment license application... [Pg.316]

Establishment license application An application to the FDA for a license to produce a biological product at a given facility. [Pg.320]

Elimination of establishment license application for specified biotechnology and synthetic biological products. Federal Register 1996, 61(94), 24227-24233. [Pg.1666]

FDA Final Rule Elimination of Establishment License Application for Specified Biotechnology and Specified Synthetic Biological Products (61 FR 24227 May 14, 1996)... [Pg.728]

Until recently, permission to market a biologic required two appheations one to obtain a product license appHcation (PLA) for the biologic itself and another for approval of the facility where the biologic would be prepared, that is, an establishment license application. The 1997 FDA Modernization Act amended the PHS Act by ehminating the separate product and establishment hcense applications in favor of a single biologies Hcense application (BLA), which, like the PMA or PDP for devices, includes an evaluation of compliance with appropriate quality controls and current cGMP as part of the assessment of the safety and efficacy of the product in question. [Pg.734]

See other pages where Establishment license application is mentioned: [Pg.147]    [Pg.243]    [Pg.85]    [Pg.15]    [Pg.81]    [Pg.533]    [Pg.52]    [Pg.45]    [Pg.61]    [Pg.616]    [Pg.101]    [Pg.103]    [Pg.110]    [Pg.111]    [Pg.113]    [Pg.9]    [Pg.2]    [Pg.157]    [Pg.976]    [Pg.1782]    [Pg.161]    [Pg.531]    [Pg.147]    [Pg.186]    [Pg.368]    [Pg.749]    [Pg.39]   
See also in sourсe #XX -- [ Pg.147 , Pg.148 ]



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Establishing

Licensed

Licensing

Licensing, license

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