The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: ANDA Submissions – Refuse-to-Receive Standards:Questions and Answers



This draft guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and certain prior approval supplements (PASs) to ANDAs

Go back

GMP Conferences by Topics