FDA Generic Drug Office Will Accept Drug Development Queries Only From Manufacturers

FDA's generic drug office laid out firm guidelines about the kinds of drug development questions it will accept and from whom -- saying in guidance released this week that controlled correspondence will be limited to entities directly involved in drug development, and that correspondence related to citizen petitions and pending regulations will not be answered ahead of official FDA action. Stakeholders generally praised the guidance as clarifying what meets the definition of controlled correspondence tied to response timelines under the...