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What is the FDA eSTAR program?

eSTAR is the only available electronic submission template to prepare 510(k) electronic submissions. eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission.

What is the main purpose of generic drug User Fee Act?

GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and improve upon the predictability of the review process.

How much is the CMO facility fee?

FDA OTC Monograph Drug registration fee for the year 2023 is USD 26,153 for MDF Facility and USD 17,435 for CMO Facility. OTC Monograph Drug facilities registered with FDA from January 1, 2022, through December 31, 2022, are liable for the FY 2023 FDA fees.

How much does it cost to file an ANDA?

I. Background Generic drug fee categoryFees rates for FY 2024Abbreviated New Drug Application (ANDA)$252,453Drug Master File (DMF)94,682FacilitiesActive Pharmaceutical Ingredient (API)Domestic40,46410 more rows Jul 28, 2023

What is the FDA guidance date format?

FDA recommends that the expiration date appear in YYYY-MM-DD format if only numerical characters are used or in YYYY-MMM-DD if alphabetical characters are used to represent the month.

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What is FDA pre submission?

Q-Sub Type: Pre-Submissions A formal written request for feedback from FDA to help. guide product development and/or application preparation. Voluntary program. No user fees.

What is FDA Form 3514?

Form FDA 3514, or the CDRH Premarket Review Submission Cover Sheet, is a voluntary form used to help provide basic administrative info for all types of premarket notification submissions.

What is an FDA Form 1572?

The investigators signature on this form constitutes the investigators affirmation that he or she is qualified to conduct the clinical investigation and constitutes the investigators written commitment to abide by FDA regulations in the conduct of the clinical investigations.

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