Zdrowie i gospodarka · 15.07.2014
Draft Guidance for Industry on Substantial Equivalence Reports; Manufacturer Requests for Extensions or To Change the Predicate Tobacco Product; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Substantial Equivalence Reports: Manufacturer Requests for Extensions or To Change the Predicate Tobacco Product." This draft guidance provides information to tobacco product manufacturers about FDA's policies on manufacturer requests for extensions of time to respond to deficiencies that FDA has identified, and manufacturer requests to change the predicate tobacco product, in substantial equivalence (SE) reports.