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Arizona Department of Corrections, Rehabilitation & Reentry (ADCRR) Prison Rape Elimination Act (PREA) Acknowledgment All volunteers must submit signed acknowledgment to supervisor. This is to acknowledge
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What is annual prea and part?
Annual PREA (Pediatric Research Equity Act) and Part refers to the report required to be submitted by pharmaceutical companies and sponsors detailing their pediatric studies conducted during the year.
Who is required to file annual prea and part?
Manufacturers of drug products and biological products that have received a pediatric study requirement from the FDA are required to file the annual PREA and Part.
How to fill out annual prea and part?
To fill out the annual PREA and Part, companies must provide required data regarding their pediatric studies, including study progress, results, and any difficulties encountered, using the FDA's electronic submission standards.
What is the purpose of annual prea and part?
The purpose of the annual PREA and Part is to ensure that pediatric populations are appropriately studied for the safety and efficacy of drugs and biologics, facilitating data-led policies for pediatric medication.
What information must be reported on annual prea and part?
Information that must be reported includes the status of pediatric studies, any findings from those studies, challenges faced, and proposed timelines for completion.
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