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How do I get a pre IND number?

What Needs to be Completed Prior to Requesting a PIND Meeting? The first step to prepare for a PIND meeting is to request a pre-assigned application number. For CDER, this is considered the PIND number. The PIND number can be requested in one of two ways for a drug: Using the FDAs NextGen Portal, or via email.

How long does it take to get an IND number?

The FDA is required to respond to an IND sponsor within 30 calendar days of receipt of a complete IND application. An IND goes into effect 30 days after the FDA received the SI may begin the study 30 days after FDA receives the IND application.

What is the FDA drug listing number?

Each listed drug product is assigned a unique 10-digit, 3-segment number. This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA.

What is the FDA NDA number?

New Drug Application (NDA) Number This six digit number is assigned by FDA staff to each application for approval to market a new drug in the United States. A drug can have more than one application number if it has different dosage forms or routes of administration.

What is the FDA application number for drugs?

Application Number Definition. What exactly is a pre-assigned application number? A pre-assigned application number is a unique six-digit number, e.g., 012345, assigned to sponsors to enable them identify their application. This number is required any time a submission is made to an eCTD application.