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Regulatory News | 27 January 2016 | By Zachary Brennan
To help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval, the US Food and Drug Administration (FDA) has published draft product-specific recommendations for 31 different active pharmaceutical ingredients (APIs) and revised recommendations for 11 APIs.
The myriad new draft guidance documents focus on what types of bioequivalence (BE) studies may need to be conducted to obtain ANDA approval. Each document also contains information on what analytes should be measured, what dissolution test methods should be used and sampling times.
“Different types of evidence may be used to establish bioequivalence for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both,” FDA says. “The selection of the method used to demonstrate bioequivalence depends upon the purpose of the study, the analytical methods available, and the nature of the drug product.
New draft guidance was released for the following APIs:
The agency also released revised recommendations for the following APIs:
The agency also pointed industry to draft guidance from 2013 as the initial step for selecting methodology for generic drug product development.
The public has two months to submit comments on the recommendations before they are made final. Comments should be submitted to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015.
Product-Specific Recommendations for Generic Drug Development
Federal Register Notice
Tags: bioequivalence studies, active ingredients, ANDAs, FDA draft guidance