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# Timely PSGs Can Spur ANDA Submissions: CDER Research
- URL: https://www.fdaweb.com/timely-psgs-can-spur-anda-submissions-cder-research/
- Published: 2020-10-29T12:00:00.000Z
- Updated: 2026-09-14T16:34:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147984

CDER researchers say that timely development of product-specific guidances, including those for complex generic drugs, along with prioritizing complex generic drug research, may facilitate ANDA submissions and promote generic drug price competition. A CDER *Regulatory Science Impact Story* [post](https://www.fda.gov/drugs/regulatory-science-action/cder-study-factors-may-predict-likelihood-generic-drug-marketing-applications?ref=fdaweb.com) describes Center research into the factors that may predict the likelihood of generic drug marketing applications.

The study reviewed all ANDA submissions for 400 branded drugs for which it became lawful to submit an NDA between 2011 and 2017\. Of the 400, 140 were originally approved as new chemical entities (NCE) and 260 did not have NCE exclusivity.

ANDA submissions occurred for more than half of the NCE products within the first two weeks after those ANDAs could be lawfully submitted, the report says. For these drugs, an application for a generic was more likely to occur if the innovator drug had generated higher revenues.

For non-NCE drugs, the data suggested a strong positive association between the availability of a published product-specific guidance before an ANDA submission and an increased likelihood of ANDA submission.

“Patents did not have a significant effect on the likelihood of ANDA submissions,” the study says…. “FDA’s Office of Generic Drugs will continue to communicate best practices and clear recommendations before NCE drugs become eligible for generic competition to help ensure timely ANDA submissions and thus increase generic drug price competition.”