This site visit program is designed to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as the challenges that impact a drug’s developmental program and commercial life cycle. The goal of these visits is to provide OPQ staff exposure […]
FDA is planning to implement eCTD validations in 2021 specific to submissions containing study data. FDA published the TRC to assist industry in understanding when a submission containing study will be subject to these study data eCTD validations.
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension, or have failed to request approval for a required pediatric formulation.
You can help stop the spread of COVID-19 disease by washing your hands with soap and water for 20 seconds every time. If soap and water are not available, alcohol-based hand sanitizers can be used if they contain at least 60% alcohol and are used properly.
The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
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