FDA to set up abbreviated pathway for complex products

Non‐Biological Complex Drugs/Polices & Legislation | Posted 21/10/2016 post-comment0 Post your comment

As part of the Generic Drug User Fee Amendments (GDUFA II) reauthorization recently agreed with industry [1], the US Food and Drug Administration (FDA) has committed to setting up a new approval pathway for drugs with complex active ingredients and formulations, as well as for drug-device combinations.

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As part of this commitment, the agency has announced in the Federal register a public meeting, which will take place on 21 October 2016. FDA is therefore requesting comments on its proposals, including its newly proposed GDUFA II pre- abbreviated new drug application (ANDA) programme for complex products.

FDA defines complex products as including products with complex active ingredients, formulations, routes of delivery, or dosage forms; complex drug-device combination products; and other products where complexity or uncertainty concerning the approval pathway or possible alternative approach would benefit from early scientific engagement.

The purpose of the proposed GDUFA II pre-ANDA programme for complex products is to clarify regulatory expectations for prospective applicants early in product development, help applicants develop more complete submissions, promote a more efficient and effective review process, and reduce the number of review cycles to obtain ANDA approval of complex products.

In addition, FDA has said that it would strive to issue product-specific guidance for complex products as soon as scientific recommendations are available.

Comments and suggestions on FDA’s proposals should be submitted within 30 days of publication in the Federal Register of the notice announcing the availability of the draft guidance, i.e. by 7 November 2016. Electronic comments can be submitted to www.regulations.gov and written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, USA.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA and industry agree on terms of GDUFA II reauthorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 21]. Available from: www.gabionline.net/Policies-Legislation/FDA-and-industry-agree-on-terms-of-GDUFA-II-reauthorization

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Source: Federal Register

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