www.fdanews.com/articles/122953-pet-drugmakers-get-new-gmps-in-final-rule-guidance
PET Drugmakers Get New GMPs in Final Rule, Guidance
December 14, 2009
Commercial manufacturers of approved positron emission
tomography (PET) drugs will have to comply with good manufacturing practices (GMPs) for their products beginning Dec. 12, 2011, a new final rule and accompanying guidance say.
Producers also will have to apply for an NDA or ANDA by then, and the agency expects to issue guidance for such applications soon, Jane Axelrad, CDER’s
associate director for policy, said during a press briefing.
Washington Drug Letter
Washington Drug Letter