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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration FDA Inspection Records Receipt Confirmation StateRequesting Office Street AddressCityTo: Name of Individuality of Individual Code.
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FAQ
Theoretically, Form FDA 483s are public information and, thus, are available through the FDA's Freedom of Information Act Office. So, any Form FDA 483 can be requested by anyone. That said, requesting a 483 can be costly and may take a lot of time.
Difference Between NDA and ANDA If the NDA is approved, then the product may be marketed in the United States. ANDA means Abbreviated New Drug Application. An abbreviated new drug application (ANDA) contains data that, when submitted to the FDA, provides for the review and ultimate approval of a generic drug product.
Examples of recently issued 483s are available in ORA's Electronic Reading Room. Questions regarding Inspection Observations may be directed by email to FDAInspectionsObservations@fda.hhs.gov.
The form provides the FDA with the information required of applicants who submit certain human drug, biological product, and device applications, including Investigational New Drug Applications (IND) and new clinical protocols submitted as an amendment to an existing IND.
If FDA finds a company's 483 response inadequate, it could result in a warning letter. If issues continue to occur there could even be additional actions such as prosecution or civil penalties. The most drastic action the Agency could take is a consent decree.
GDUFA enables FDA to assess industry user fees to bring greater predictability and timeliness to the review of generic drug applications.
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
We have developed Form FDA 3794, the Generic Drug User Fee Cover Sheet, available at https://.fda.gov/ industry/fda-user-fee-programs which requests the minimum necessary information from generic drug applicants to account for and track user fees and to determine the amount of the fee required.
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