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Good ANDA Submissions: Stakeholders Seek Tweaks to Draft Guidance

Posted 08 March 2018 | By Zachary Brennan 

Good ANDA Submissions: Stakeholders Seek Tweaks to Draft Guidance

Coming off 2017’s record abbreviated new drug application (ANDA) approvals, the agency released draft guidance to try to bring down the number of cycles companies go through to win approvals.

Industry groups the Association for Accessible Medicines (AAM) and IPEC-Americas sought clarity and additions to several sections of the draft, while over-the-counter drugmaker Perrigo raised questions about how many generic drug guidance documents are out there.

IPEC-Americas noted its members’ concerns related to the need for a better understanding of expectations for atypical actives, saying it has requested that USP establish an expert panel on atypical actives.

First-Cycle Approvals

AAM noted the recent improvements in first-cycle final approvals, which was what FDA had said was the impetus behind releasing the draft and a MAPP in January.

“In the first-quarter of GDUFA II (FY2018), FDA issued 59 first-cycle final approvals (about 24% of total final approvals),” AAM said. “By comparison, in FY2017, FDA’s first-cycle approval rate was only 12.8%. This progress is encouraging, and the draft guidance offers opportunity for additional clarity regarding FDA’s expectations related to patents and exclusivity, labeling, product quality, and bioequivalence deficiencies.”

AAM also sought additional clarification on commercially available starting materials “for which the route of synthesis is not required according to ICH Q11, Q&A but only basic information (i.e. chemical name, chemical formula, molecular weight, information on impurity profile) which can be obtained from the literature.”

The group added that including full study reports for in silico predictions may substantially increase the size of an ANDA, and that it believes a summary of the report for each compound should suffice.

Guidance Documents

Perrigo, meanwhile, took issue with a line in the draft encouraging ANDA applicants to review applicable FDA guidance.

Perrigo noted that as of 5 March 2018, FDA lists 48 generic drug guidance documents, 17 of which are drafts, whereas in this draft on ANDA submissions, 35 guidance documents including drafts, are referenced in the document.

“In the final guidance, please tabulate all guidance documents considered applicable to ANDAs and cross reference these by number as applicable throughout this guidance,” Perrigo said. “Additionally, while the guidance database is an improvement, it would be helpful to have a keyword tag or organization system to allow sponsors to more readily identify which guidance documents are applicable to their specific product. We recognize and appreciate that the MAPP instructs assessors to refer to specific guidance documents when communicating deficiencies to applicants.”


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