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Product license application

LIST NUMBERS OF ALL INVESTIGATIONAL NEW DRUG APPLICATIONS <21 CFR Pan 312), NEW DRUG OR ANTIBIOTIC APPLICATIONS (S CFR Part 3U). DRUG MASTER FILES (2i CFR Pan 314.420A AND PRODUCT LICENSE APPLICATIONS <21 CFR Part 601) REFERRED TO IN THIS APPLICATION. [Pg.92]

The FDA regulations or guidelines prescribe the types of safety tests for a particular product. Sponsors may conduct the studies in their own laboratories or have them performed by a contract laboratory, a university, or some other type of laboratory. The sponsor submits the study reports to the FDA in food and color additive petitions, investigational new drug applications, new drug applications, new animal drug applications, biological product license applications, and other requests for permission to market a product. [Pg.12]

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

Type of submission Product license application (Ceredase), Biologic license application (Cerezyme)... [Pg.256]

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]

Each Lot of dried pmduct shall be (csleJ fur lesidvat trihisiure by an appmvsd method on file in the product license application. ... [Pg.201]

See other pages where Product license application is mentioned: [Pg.147]    [Pg.763]    [Pg.48]    [Pg.406]    [Pg.243]    [Pg.439]    [Pg.85]    [Pg.81]    [Pg.138]    [Pg.140]    [Pg.194]    [Pg.196]    [Pg.196]    [Pg.199]    [Pg.224]    [Pg.258]    [Pg.259]    [Pg.261]    [Pg.263]    [Pg.289]    [Pg.334]    [Pg.536]    [Pg.36]    [Pg.52]    [Pg.224]    [Pg.45]    [Pg.61]    [Pg.616]    [Pg.101]    [Pg.103]    [Pg.110]    [Pg.111]    [Pg.113]    [Pg.9]    [Pg.2]    [Pg.13]    [Pg.157]    [Pg.199]    [Pg.733]    [Pg.2471]    [Pg.319]   
See also in sourсe #XX -- [ Pg.183 ]

See also in sourсe #XX -- [ Pg.147 , Pg.148 , Pg.226 ]

See also in sourсe #XX -- [ Pg.749 ]



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