lunes, 23 de enero de 2017

FDA webinar: Referencing Approved Drug Products in Abbreviated New Drug Application (ANDA) Submissions

FDA's Center for Drug Evaluation and Research has posted a pre-recorded webinar: "Draft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions." This webinar, and the guidance it accompanies, are intended to help applicants submitting an abbreviated new drug application (ANDA) seeking approval of a generic drug to identify:
  • A reference listed drug (RLD), i.e., a previously approved drug product for which an applicant seeks approval of a generic drug;
  • a reference standard, i.e., the previously approved drug selected by FDA that an applicant must use in conducting any in vivo bioequivalence testing required to support approval of its ANDA; and
  • the basis of submission for the ANDA.
Additional Resources:
For questions concerning the webinar, please contact CDER SBIA at: (866)-405-5367 | (301)-796-6707

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