What if a sponsor does not comply with an FDA requirement to perform a pediatric assessment within the set time?
Related Questions
- Does my organization need to document every time a chart is accessed in order to comply with the "Accounting of Disclosures" requirement under the HIPAA Privacy Rule?
- What if a sponsor does not comply with an FDA requirement to perform a pediatric assessment within the set time?
- Does a sponsor HAVE to conduct pediatric studies if it receives a Written Request from FDA?