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...This Plan suggests criteria, components, and formats that, combined, provide guidance for developing.....criteria, includes the suggested components, and substantially conforms to the guidelines in Chapter 3,will count toward.....Establish criteria for the development and distribution of written prescription medicine..
http://www.fda.gov/cder/Offices/ODS/keystone.pdf (score=100)
MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....recommended for inclusion in the application regarding the components, manufacturing.....elastomeric, plastic components or coatings of the container and closure system when in..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=34)
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