US FDA issues draft guidance on ANDA submissions, seeks industry views before November end

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The US FDA issued a set of draft guidelines for ANDA Submissions.
The guidance, in a question and answer format, addresses general issues about ANDA, filing decisions, review and deficiencies related to Drug Master Files (DMFs), product quality, and bioequivalence (BE) and clinical reviews. These according to the regulatory authority are intended to clarify the deficiencies that may cause FDA to refuse to receive (RTR) an ANDA. An RTR decision indicates that the regulator has determined that an ANDA is not a substantially complete application to permit a substantive review. US FDA has sought industry comments on the same before November end

According to Prema Desai, pharma consultant, the objective of this guidance is to assist sponsors in demonstrating, through an evaluation of the analytical similarity of the proposed biosimilar and reference product.

“The analytical similarity assessment plan shall be carefully designed to identify and address all factors that could impact the determination about whether the proposed biosimilar is highly similar to the reference product. An analytical similarity assessment involves a comparison of structural or physicochemical and functional attributes using multiple lots of the proposed biosimilar product and the reference product. Besides, the analytical similarity should be assessed by using appropriate statistical methods to evaluate the analytical data. Use of a risk-based approach is recommended in the analytical similarity assessment of quality attributes,” she added.

FDA evaluates each submitted ANDA individually to determine whether it can be received. The RTR standards guidance applies to original abbreviated new drug applications and certain prior approval supplements consistent with the current practices.

“These include those in which the applicant is seeking approval of a new strength, reformulation of a drug product that does not require a new original ANDA submission, return of a discontinued product to the market, and Rx-to- OTC switches for all conditions of use,” stated the regulatory authority.

Further, the regulatory authority may ‘Refuse to Receive’ a resubmission for multiple reasons. This is not limited to the failure to provide a comprehensive response to the deficiencies identified in product-specific bioequivalence.

Besides the FDA is of the view that one week provides an industry applicant sufficient time to review the regulatory action. The time is also ample to determine whether the applicant would like to pursue a request for reconsideration. It also ensures that applicants submit requests for reconsideration of recent regulatory actions. In the case of minor deficiencies, any matters that will be challenged should be reviewed, analyzed, and addressed within a week. However, the regulatory authority recognizes that an applicant will require some time to identify, coordinate, and compile the information necessary to submit a response to the RTR determination.

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