# FDA 483 - National Cancer Institute, Cancer Therapy Evaluation Program - July 17, 2014

Source: https://www.globalkeysolutions.net/records/483/national-cancer-institute-cancer-therapy-evaluation-program/df2145ec-53be-4693-bace-5d10a2c865b2

> FDA 483 for National Cancer Institute, Cancer Therapy Evaluation Program on July 17, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: National Cancer Institute, Cancer Therapy Evaluation Program
- Inspection Date: 2014-07-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: The FDA inspected the National Cancer Institute, Cancer Therapy Evaluation Program, revealing significant deficiencies in the oversight of clinical investigations. Observations included failures to ensure investigator qualifications, adequately monitor study progress, obtain complete FDA-1572 statements, and collect required financial disclosure information from investigators. These issues indicate a lack of adherence to regulatory requirements for clinical trial conduct.

## Related Documents

- [EIR - 2014-07-17](https://www.globalkeysolutions.net/records/eir/national-cancer-institute-cancer-therapy-evaluation-program/0ea41923-e58e-4119-93c8-059ec001ad62)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/courtney-n-long/32118415-bc77-4ac2-8f90-947e43cf10ff)

Company: https://www.globalkeysolutions.net/companies/national-cancer-institute-cancer-therapy-evaluation-program/8cc7f4d2-3770-43d0-adba-33439499bb74

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e