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# No Big Delays from IND Holds: Lapteva
- URL: https://www.fdaweb.com/no-big-delays-from-ind-holds-lapteva/
- Published: 2016-08-04T12:00:00.000Z
- Updated: 2026-09-14T21:21:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136410

CDER’s **Larissa Lapteva** says that clinical holds placed on INDs do not lead to “substantial” delays in drug development. Interviewed for a [*CDER Conversation*](http://www.fda.gov/Drugs/NewsEvents/ucm514825.htm?ref=fdaweb.com), she said that the CDER Office of New Drugs’ rare diseases program began collecting data specifically related to rare disease applications in 2010\. “At the time,” she says, “there were concerns from the rare disease community that the pace of pharmaceutical development was too slow. We needed to have a better understanding of the drug development environment to address these concerns.”

The research found that of 1,410 initial INDs received from 10/2012 through 9/2013, only 125 (9%) were placed on hold during the first 30 days after submission to the agency. “It was also interesting to find that of the INDs placed on clinical hold, more than half of the applications came off hold within one year,” Lapteva reports. “Some 76% of rare disease INDs placed on hold became active within the first year, as did 45% of the common disease INDs.”

According to the conversation report, the most commonly cited deficiencies leading to a clinical hold were product quality issues, followed by clinical and toxicology issues. Lapteva says that a very small proportion of applications were placed on hold for combinations of multiple deficiencies.

Asked about stakeholder concerns that clinical holds are used too often and affect drug development, Lapteva says the analysis showed that there were no meaningful differences in rates or reasons for holds between IND applications submitted for drug development in rare versus common disease or between commercial and research INDs. “We understand these concerns about earlier access and try to work with drug sponsors to move drug development forward but not to expose study participants receiving the treatments to unnecessary and avoidable serious risks,” she says.

Lapteva urged drug sponsors to be familiar with current regulatory expectations and consider existing guidelines for new drug product development.