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Individuals participating in a DAC (Development Assistance Committee) study that requires form 363 for data collection and reporting.

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What is dac study form 363?

DAC Study Form 363 is a form used to report study data for new drug applications (NDAs) or abbreviated new drug applications (ANDAs).

Who is required to file dac study form 363?

The pharmaceutical company or sponsor conducting the study is required to file DAC Study Form 363.

How to fill out dac study form 363?

DAC Study Form 363 must be filled out with accurate and detailed information regarding the study data, following the instructions provided by the FDA.

What is the purpose of dac study form 363?

The purpose of DAC Study Form 363 is to provide the FDA with essential study data related to drug applications to ensure the safety and efficacy of the drugs.

What information must be reported on dac study form 363?

Information such as study design, methodology, results, adverse events, and statistical analysis must be reported on DAC Study Form 363.

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