FDA Seeks Guidance On Applications for Generic Drugs

FDA Seeks Guidance On Applications for Generic Drugs Photo: Ekem via Wikimedia Commons Johnson & Johnson Headquarters in New Brunswick, New Jersey.

The Food and Drug Administration wants to make the regulatory process for generic drugs go faster.

The agency is seeking comments on its draft guidance for generic drug applications, including input about common deficiencies in abbreviated new drug applications. Called ANDAs, these are usually submitted for drug products that are the same as an already-approved drugs or listed drugs.

Comments must be submitted by Aug. 11.

Elizabeth Giaquinto, regulatory counsel in FDA’s Office of Generic Drugs, said in a webinar that Congress voted in 2012 to speed up the availability of generic drugs, and that the agency is attempting to decrease the number of review cycles for original abbreviated new drug applications submitted electronically.

The agency has promised to review and act on original ANDA submissions within 10 months of the date of submission beginning on Oct. 1, 2016.

ANDAs are to be submitted in the CTD electronic format, which was developed by the International Conference on Harmonisation to streamline the submission requirements in the United States, the European Union and Japan.

The guidance is a detailed discussion of how generic drugmakers can improve the quality of their applications, including administrative information like complete facility and testing information and patent information and certification, their CTD summaries, information about quality such as good manufacturing practices in sterilizing the substances used in sterile drug products, reports of nonclinical studies and reports of clinical studies.

Amaris Elliott-Engel contributes to law.com.

LOAD MORE