How long does it take FDA to approve NDA?

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 safety update?

A periodic safety update report (PSUR) is a report that provides an updated overview of the benefits and risks of a medicine.

What is a 74 day letter from FDA?

Day-74 (Deficiencies Identified) Letter – a letter notifying the applicant of issues identified during the filing review phase that were not communicated in the filing letter.

How long does FDA priority review take?

within 6 months
A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review).

What is the FDA BLA?

The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.

What is a rolling review FDA?

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

How do I get a FDA Fast Track?

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

What is NDA filing?

NDA Filing means a New Drug Application filed as a result of activities under this Agreement with the FDA, or the equivalent application to the equivalent agency in any other country of the Territory, the filing of which is necessary to market and sell a Product, including all amendments and supplements to any of the …

What is a 120 day safety update?

120 Day Safety Update (also referred to as 4 Month Safety Update, 4MSU) The 120 Day Safety Update contains any new safety information learned about the drug that may reasonably affect the statement of contraindications, warnings, precautions, and adverser reactions in the draft drug labelling.

What safety information was available in the NDA submission?

The most important safety information available for review in the NDA submission was the safety data obtained from the DB study EUR-1008-M. The 120-Safety Update was also submitted during the review cycle (dated 16-May-2008).

What are the requirements of the NDA for a drug?

Although the exact requirements are a function of the nature of a specific drug, the NDA must provide all relevant data and information that a sponsor has collected during the product’s research and development.

Why does the FDA conduct inspections of the NDA?

More specifically, the FDA conducts inspections to: verify the accuracy and completeness of the manufacturing-related information submitted in the NDA; evaluate the manufacturing controls for the preapproval batches upon which information provided in the NDA is based;