FDA Releases ANDA Submission Guidance

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The agency published draft guidance on good practices for submitting abbreviated new drug applications.

On Jan. 3, 2018, FDA published draft guidance detailing good practices for the submission of abbreviated new drug applications (ANDAs) as part of its Drug Competition Action Plan. In the guidance document, the agency highlights common deficiencies previously found in ANDAs that could lead to a delay in approval. Recommendations for avoiding delays and minimizing the review time are also included.

Specifically, the guidance details the requirements for patent and exclusivity protection information, which includes documentation of legal action filings, resolutions or appeals, new or revised Orange Book information, paragraph IV certification, amendments to an approved ANDA, and notification of commercial marketing.

Clarification on labeling requirements includes information on draft container and carton labeling, color differentiation, label formatting, and parenteral packaging. Quality and bioequivalence requirements are also discussed.

The agency also published guidance for agency staff, entitled Manual of Policies and Procedures (MAPP)–Good ANDA Assessment Practices. The guide will enhance the efficiency of the ANDA review process.


“The policies we’ve announced today and those that we’re anticipating in early 2018 represent our ongoing work on the Drug Competition Action Plan-one of the FDA’s highest priorities in 2018. In the coming year, we’ll be taking additional steps to improve our own practices and to help guide industry to make sure their generic drug applications can be acted upon as efficiently as possible. For example, we’ll be building on our initiatives to accelerate generic entry of complex generics, which include medicines like metered dose inhalers used to treat asthma, as well as some costly injectable drugs, which are sometimes hard to copy,” FDA Commissioner Scott Gottlieb, MD, said in a statement published on FDA.gov.

Source: FDA