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Generic Drugmakers Get Tips on Speeding Up FDA Product Reviews

Jan. 26, 2022, 5:58 PM

Drugmakers should include consistent labeling information and detailed data on active ingredients in generic drug applications to avoid slowing down the FDA review process, the agency said in guidance Wednesday.

The guidance highlights common deficiencies found in abbreviated new drug applications (ANDAs) that can delay the approval of generic drugs. The aim of the documents is to boost efficiency and limit the number of review cycles needed to bring a new low-cost drug to market.

The recommendations build off of the Food and Drug Administration’s Drug Competition Action Plan “to increase competition in the market for drugs, facilitate entry of ...

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