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How do I know if I am FDA approved?

To find out if a drug is approved by FDA, consumers can use two different Internet sites: Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939. The FDA Orange Book contains drugs approved by FDA under New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).

How long does FDA approval normally take?

The clinical trial phase can take years to complete. However, once research has shown that the drug is safe and useful, the FDA typically reviews and either approves or denies an application for a new drug within 6 months.

What is the difference between FDA cleared and FDA approved?

FDA Approved is a higher standard, because the safety and effectiveness of the specific product has been tested. FDA Cleared is a lower standard, and in many cases the product is cleared because it is similar to an existing product, rather than that it has passed rigorous independent safety trials.

Is a PDUFA date the approval date?

Once the FDA accepts a filing for the approval of a drug, the agency must complete its review process within 10 months in most cases. The date at the end of the review period is referred to as the PDUFA date.In some instances, the FDA grants Priority Review status to the regulatory filing for a drug.

Does PDUFA date mean approval?

The PDUFA date thus serves as a best estimate of when a decision on a New Drug Application or a Biologics License Application would be forthcoming. This response may be a decision to approve the application or a Complete Response Letter (CRL).

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What is the normal timeline for FDA approval?

FDA Review Once FDA receives an NDA, the review team decides if it is complete. If it is not complete, the review team can refuse to file the NDA. If it is complete, the review team has 6 to 10 months to make a decision on whether to approve the drug.

What is an FDA action date?

The action date tells when an FDA regulatory action, such as an original or supplemental approval, took place.

How do I check my FDA approval status?

Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number. Look up the drug in the Orange Book or the biological product in the Purple Book.

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