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# CDER Sees No Negatives with Expanded Access Decisions
- URL: https://www.fdaweb.com/cder-sees-no-negatives-with-expanded-access-decisions/
- Published: 2017-05-15T12:00:00.000Z
- Updated: 2026-09-14T22:23:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138690

CDER officials say expanded access decisions have not led to a negative regulatory decision regarding a drug application, and there was only one instance where safety events under expanded access had a potentially negative effect on product labeling. “Concern that expanded access will have a negative impact on drug development and review is not based on the evidence and is unwarranted,” they write in the[ latest issue](http://journals.sagepub.com/doi/abs/10.1177/2168479017707800?journalCode=dijc&ref=fdaweb.com) of *Therapeutic Innovation & Regulatory Science*.

  
The officials say that 321 regulatory approval decisions were examined by CDER and it found that 28% of the drugs had prior expanded access. “The approval rate for drugs with expanded access (84%) was higher than those that did not (76%),” they write. “None of the negative regulatory marketing decisions were based on the adverse experiences reported under expanded access. The vast majority of deaths and serious adverse events that occurred under expanded access were not interpreted by FDA to be due to the investigational drug and did not affect product labeling.”