What is a application number?
What is a application number?
An Application Number is a unique identifier for the application which includes a two digit series code followed by a six digit serial number which is assigned by the USPTO.
How do I get an FDA IND number?
How to Gain Access
- Before you request a pre-assigned application number, apply for a secure email with the FDA by contacting [email protected].
- Send one email per application number request to [email protected].
- A pre-assigned number will be issued within 3 business days.
How do I check the status of my FDA approval?
If consumers would like more information, they can call 301-827-4573 or 888-INFO-FDA (1-888-463-6332). Questions can also be submitted by e-mail to [email protected].
How many INDs are filed per year?
Background: The Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) receives about 1500 initial Investigational New Drug applications (INDs) per year.
What is FDA IND number?
For investigational biological products regulated by CBER, call 800-835-4709 or 240-402-8020 . For all other investigational drugs, call 301-796-3400 . After working hours, call FDA’s Office of Emergency Operations at 1-866-300-4374 or 301-796-8240 .
What is FDA IND application?
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
How long does it take for FDA approval?
The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application, or submit a Premarket Approval (PMA) application.
What is an EIND?
Emergency Investigational New Drug (EIND) Applications for Antiviral Products.
Does FDA approve Inds?
But since IND applications are not formally approved, the FDA might not provide feedback to the Sponsor if there are no concerns surrounding the IND. If the Sponsor does not hear from the FDA within 30 days, the IND goes into effect (becomes “active”).
