Requesting a Pre-Assigned Application number
The new way of requesting pre-assigned numbers has arrived!
Pre-assigned ANDA number requests can now be submitted via the CDER NextGen Portal. Ability to submit requests for other application types, IND, NDA, BLA, and MF, are planned to be added in the next few months – stay tuned!
What are the benefits of submitting requests via the Portal?
- Ease of Use: Requesting via the Portal is easy, and all information regarding your requests is stored in one place.
- Automated confirmation: You can log in, initate a request and receive an automated confirmation of your transaction.
- Historical record: Requestor can view all transactions at any time. The Portal organizes all your request based on status (e.g. pending, closed);
How to Gain Access
- New Users
To register for an account with the CDER NextGen Portal, navigate to https://edm.fda.gov and follow the signup instructions.
- Existing Portal Users
Pre-Assignment tab was added to your account automatically – click on it when you are ready to submit a request.
In order to get assistance on registering for the CDER NextGen Portal, please reference the user guides and FAQ's. For additional support, please contact CDER Platform Support at email@example.com.
Note: If you submitted a request via portal, do not re-submit via e-mail. Portal is the preferred way of submitting requests.
For submitting via e-mail please follow the instructions below:
- Before you request a pre-assigned application number, apply for a secure email with the FDA by contacting firstname.lastname@example.org
Include the following information in your e-mail:
- Subject: Request for a Pre-Assigned
- Name of Applicant that will be on form (FDA 1571 or 356h) or transmittal letter (Master File)
- Applicant Address (street, city, state, zip code)
- Name of US Contact, Phone Number, Fax Number, Email Address
- Name of drug or Subject of Master File
- Drug Trade Name (if applicable)
If requesting for an IND, NDA, or BLA please include the following:
- Review Division, if known
If requesting for an IND, please include one of the following:
- "Commercial IND" if the product under investigation is intended to be commercialized at a later date
- "Research IND" * if the product under investigation is not intended to be commercialized at a later date. Research INDs are generally sponsored by individual investigators, academic institutions and non-profit entities. May include INDs for emergency use or other expanded access.
If requesting for a Master File please include the following:
- Manufacturing Site Name
- Manufacturing Site Address
- Master File Type (e.g. Type II, Type III, Type IV, or Type V). For information on Master File Types see the Drug Master Files (DMFs) webpage.
If requesting for an ANDA, please include the following:
- Reference Listed Drug Name and RLD Number
- Subject: Request for a Pre-Assigned
- A pre-assigned number will be issued within 3 business days.
Subject: Request for a Pre-Assigned <insert Application Type> Number
Name of Applicant
Address line 1
Address line 2
Name of U.S. Contact
The fastest and most direct route to your reviewers is through the Electronic Submission Gateway. Please consider using it for all your IND, NDA, ANDA, or BLA regulatory submissions. See Electronic Submissions Gateway for more information.
- *. When a sponsor that generally submits Research INDs, submits either a Phase 2 or Phase 3 protocol, they should select "Commercial" (eCTD requirements will apply). However, when the sponsor believes the Phase 2 or Phase 3 protocol is still solely for research, the sponsor may submit a justification explaining their rationale in the IND cover letter, along with the protocol. If the FDA agrees, then the IND will remain a “Research” IND and the eCTD requirements will not apply. Note that in all cases, expanded access INDs and protocols should be marked as “Research” on the Form 1571 and are exempt from eCTD requirements.