Get the free Freedom of Information Summary Supplemental New Animal Drug Application - fda
Show details
This document provides a summary of the supplemental new animal drug application for AQUAFLOR, an antimicrobial drug effective in controlling mortality in freshwater-reared salmonids due to furunculosis
We are not affiliated with any brand or entity on this form
Get, Create, Make and Sign dom of information summary
Edit your dom of information summary form online
Type text, complete fillable fields, insert images, highlight or blackout data for discretion, add comments, and more.
Add your legally-binding signature
Draw or type your signature, upload a signature image, or capture it with your digital camera.
Share your form instantly
Email, fax, or share your dom of information summary form via URL. You can also download, print, or export forms to your preferred cloud storage service.
How to edit dom of information summary online
In order to make advantage of the professional PDF editor, follow these steps below:
1
Register the account. Begin by clicking Start Free Trial and create a profile if you are a new user.
2
Simply add a document. Select Add New from your Dashboard and import a file into the system by uploading it from your device or importing it via the cloud, online, or internal mail. Then click Begin editing.
3
Edit dom of information summary. Add and replace text, insert new objects, rearrange pages, add watermarks and page numbers, and more. Click Done when you are finished editing and go to the Documents tab to merge, split, lock or unlock the file.
4
Save your file. Select it from your records list. Then, click the right toolbar and select one of the various exporting options: save in numerous formats, download as PDF, email, or cloud.
With pdfFiller, it's always easy to work with documents.
Uncompromising security for your PDF editing and eSignature needs
Your private information is safe with pdfFiller. We employ end-to-end encryption, secure cloud storage, and advanced access control to protect your documents and maintain regulatory compliance.
How to fill out dom of information summary
How to fill out Freedom of Information Summary Supplemental New Animal Drug Application
01
Gather all necessary documents related to the new animal drug application, including scientific studies and safety data.
02
Complete the appropriate application form required by the regulatory authority.
03
Provide a summary of the drug's purpose, intended use, and target species.
04
List all manufacturing and quality control details pertinent to the drug.
05
Include a comprehensive safety and efficacy profile based on studies conducted.
06
Prepare a section for labeling and packaging information.
07
Review and ensure compliance with all applicable guidelines and regulations.
08
Submit the application electronically or via the required submission method.
09
Await feedback or requests for additional information from the regulatory authority.
Who needs Freedom of Information Summary Supplemental New Animal Drug Application?
01
Regulatory authorities evaluating new animal drugs for safety and efficacy.
02
Pharmaceutical companies developing new animal drugs.
03
Veterinarians and agricultural professionals needing access to drug information.
04
Researchers conducting studies related to animal health and drug development.
Fill
form
: Try Risk Free
People Also Ask about
What is a supplemental new drug application?
Compilation of information on the safety and efficacy of a marketed drug that is submitted to the FDA in order to request approval to market the drug for another indication.
What is a nada new animal drug application?
NADA - A NADA is used to seek approval of a new animal drug. ANADA - An ANADA is used to seek approval of a generic new animal drug. A generic new animal drug is a copy of an approved new animal drug for which patents or other periods of exclusivity are near expiration.
What is a supplemental abbreviated new drug application?
New Drug Application (NDA) Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks. Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
What is the difference between NDA and Snda?
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
What is one of the most recent approvals for an animal drug?
Drug Approval Information DateApplication NumberProduct Name September 19, 2024 NADA 141-585 Zenrelia (ilunocitinib tablets) September 10, 2024 ANADA 200-774 Tulaject 25 (tulathromycin injection) September 5, 2024 ANADA 200-773 Tulaject 100 (tulathromycin injection) September 5, 2024 ANADA 200-795 CARPROFEN Soft Chewable Tablets18 more rows
What is supplemental new drug submission?
What is a Supplemental New Drug Submission (SNDS)? The SNDS pathway is for significant changes to an already approved drug. These modifications can impact a drug's safety, efficacy, or quality, necessitating regulatory review to ensure compliance.
What is abbreviated new animal drug application Anda?
The Abbreviated New Animal Drug Application (ANADA) process is for the approval of generic copies of new animal drug products that have been previously approved and shown to be safe and effective.
For pdfFiller’s FAQs
Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.
What is Freedom of Information Summary Supplemental New Animal Drug Application?
The Freedom of Information Summary Supplemental New Animal Drug Application is a document submitted to the FDA that provides a summary of information about a supplemental new animal drug application, allowing the public access to information about changes or new indications to an existing animal drug.
Who is required to file Freedom of Information Summary Supplemental New Animal Drug Application?
Any sponsor or manufacturer who seeks to make changes to an existing approved new animal drug, such as modifications in labeling, changes in production, or introduction of new indications, is required to file this application.
How to fill out Freedom of Information Summary Supplemental New Animal Drug Application?
The application should be filled out according to FDA guidelines, providing detailed information on the supplemental changes being proposed, including labeling, safety information, and any required data from studies supporting the changes. Careful attention should be given to following the specific format and submission protocols outlined by the FDA.
What is the purpose of Freedom of Information Summary Supplemental New Animal Drug Application?
The purpose of the Freedom of Information Summary Supplemental New Animal Drug Application is to promote transparency by providing the public with relevant details on changes made to animal drug products and ensuring that the information is accessible to consumers, veterinarians, and other stakeholders.
What information must be reported on Freedom of Information Summary Supplemental New Animal Drug Application?
The application must report information such as the identification of the drug, the nature of the supplement being proposed, the rationale for the changes, summaries of data from studies that support the change, any safety and effectiveness data, and updated labeling information.
Fill out your dom of information summary online with pdfFiller!
pdfFiller is an end-to-end solution for managing, creating, and editing documents and forms in the cloud. Save time and hassle by preparing your tax forms online.
Dom Of Information Summary is not the form you're looking for?Search for another form here.
Relevant keywords
Related Forms
If you believe that this page should be taken down, please follow our DMCA take down process
here
.
This form may include fields for payment information. Data entered in these fields is not covered by PCI DSS compliance.
