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CPR Comments on FDA Generics Rule

CPR Comments on FDA Generics Rule, the Food and Drug Administration’s proposal to revise its regulations governing the procedures for changing product labeling to reflect certain types of newly acquired information in order to extend to generic drug manufacturers the same opportunities afforded “brand name” drug manufacturers.

Type: Letters to Agencies (March 10, 2014)
PDF: CPR Comments on FDA Generics Rule
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Author(s): Sidney Shapiro, Thomas McGarity, James Goodwin
Tags: drug safety
Categories: Consumer Protection Consumer Protection

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