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Regulatory Focus™ > News Articles > Formal Meetings Between FDA and ANDA Applicants: Stakeholders Weigh Draft Guidance

Formal Meetings Between FDA and ANDA Applicants: Stakeholders Weigh Draft Guidance

Posted 20 December 2017 | By Zachary Brennan 

Formal Meetings Between FDA and ANDA Applicants: Stakeholders Weigh Draft Guidance

Drugmakers Sanofi and Teva, alongside industry groups AAM and the Bulk Pharmaceuticals Task Force, offered their comments earlier this month on new draft guidance related to formal meetings between FDA and abbreviated new drug application (ANDA) sponsors.

The Society of Chemical Manufacturers and Affiliates’ (SOCMA) Bulk Pharmaceuticals Task Force expressed disappointment that, although it participated in the Generic Drug User Fee Amendments (GDUFA II) negotiations, the draft guidance does not provide opportunities for manufacturers of active pharmaceutical ingredients (APIs) to apply to FDA for a formal meeting to enhance the development of complex drug substances.

"During GDUFA II negotiations between the FDA and industry representatives, the BPTF asked FDA negotiators if the proposed formal development meetings addressed in this Guidance would be available to API manufacturers, and the response was affirmative. The BPTF asks that FDA uphold its commitment to this agreement and clearly specify that API manufacturers may also apply for formal meetings with FDA," the group’s comment says.

Similarly, Sanofi questioned the agency: "If questions related to complex active ingredients are raised by FDA: Will the DMF [drug master file] holder be allowed to participate in sponsor meetings with FDA? How is confidentiality for Active Ingredient manufacturers guaranteed? Would the performance goals provided in this guidance be affected when a DMF is referred to?"

Teva, meanwhile, noted that FDA is asking for briefing packages to be submitted concurrent with meeting requests, though the company is calling on FDA to "consider to allow sponsors to provide an addendum to the previously submitted briefing package should there be additional data obtained from the time of initial submission to within some interval of time prior the meeting."

In the roughly five months after the submission of the briefing package, Teva said, "valuable information that could result in further rich and meaningful discussion and direction for the subject product would be in the best interest of the intent of the pre-ANDA program."

And AAM made several specific clarifications and suggestions, noting that several of its technical comments "refer to the adoption of best practices from lessons learned from PDUFA [Prescription Drug User Fee Act]."


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