New Guidance Documents: ANDA Submissions RTR / ICH E17 Multi-Regional Clinical Trials

1. Abbreviated New Drug Application Submissions-Refuse To Receive for Lack of Justification of Impurity Limits; Guidance for Industry

This guidance is intended to assist applicants preparing to submit to FDA ANDAs and prior approval supplements to ANDAs for which the applicant is seeking approval of a new strength of the drug product. The guidance highlights serious deficiencies in impurity information that may cause FDA to RTR an ANDA.  

Guidance Document

Federal Register Notice

2. E17 General Principles for Planning and Design of Multi-Regional Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry

This draft guidance describes general principles for planning and designing multi-regional clinical trials (MRCT). The draft guidance is intended to increase the acceptability of data from MRCTs as the primary source of evidence supporting marketing approval in global regulatory submissions and to thereby facilitate more efficient drug development and earlier access to medicines.

Guidance Document

Federal Register Notice

Additional newly posted guidance documents are available on our Guidances webpage.