Home » FDA Requests Comments on Authorized Generics Rule
FDA Requests Comments on Authorized Generics Rule
The FDA is requiring NDA holders to ensure they send annual reports with information on authorized generic drugs that the agency must collect under a new law. Currently, NDA holders are not required to report they are marketing an authorized generic drug. Under a direct final rule and a companion proposed rule, the FDA also asks NDA holders to report the date on which they stopped distributing an authorized generic. Comments are due Dec. 15, and the effective date of the rule is Feb. 11, 2009.
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