Product Application and Petition Review Process

Animal and Veterinary

The Center for Veterinary Medicine reviews applications for new and generic animal drugs, new indications for already approved products, veterinary devices, and animal feed.

• Information and types of notifications that are provided to sponsors during the new animal drug application review process
• From Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process
• New Animal Drug Applications
• How the FDA Regulates Veterinary Devices
• General Animal Drug and Patent Term Restoration Act (Generic drug approval process)
• Food Additive Petition
• Veterinary Feed Directive
• Veterinary Master Files
• Electronic Submissions
• CVM's policy and procedures manual for information about meeting with FDA about a planned product submission or application under review (PDF - 81KB)

Drugs 

FDA's Center for Drug Evaluation and Research (CDER) evaluates new prescription and some over-the-counter (OTC) drugs for safety, effectiveness, and quality before they can be marketed in the United States. Our evaluation, called a review, ensures that the drugs we approve meet our rigorous standards. For more information about the processes, visit the links below:

• Prescription Drug Review Process
• Generic Drug Review Process
• OTC Drug Review Process
• Guidance for Industry: Time and Extent Applications (PDF - 46KB)
• Guidance for Industry Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (PDF - 164KB)
• Secure Electronic Email
• Electronic Regulatory Submission and Review
• Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants  (PDF - 89KB)

Food

The Center for Food Safety and Applied Nutrition reviews petitions for food and color additives and notices submitted for food contact articles and generally recognized as safe (GRAS) substances.

• Determining the Regulatory Status of a Food Ingredient
• Pre-Petition Consultations for Food Additives and Color Additives
• Petition Process for Food and Color Additives, Preparation of Notifications for Food Contact Articles and Generally Recognized as Safe (GRAS) Substances

• Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety; Draft Guidance - PDF Version (553KB)

• Providing Regulatory Submissions in Electronic Format — General Considerations - PDF Version (288KB)

• Guidance for Industry: Preparation of Food Contact Notifications: Administrative

Medical Devices

The Center for Devices and Radiological Health reviews premarket approval applications for new medical devices and 510(k) notifications for devices that may be substantially equivalent to already marketed devices. In addition, any medical device that emits radiation is subject to this reporting requirement for radiation-emitting products.

• Premarket Notification (510k)
• FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
• Premarket Notification [510(k)] Status Request Form
• Premarket Approval (PMA)
• FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
• Humanitarian Device Exemption

• Electronic Copies for Pre-Market Submissions, General Information - Questions and Answers

• Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
• Information and types of notifications are provided to sponsors during the medical device application review process

• Final Guidance for Industry and for CDRH Staff: Early Collaboration Meetings Under the FDA Modernization Act (FDAMA)

• Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry

Radiation-Emitting Products

The Center for Devices and Radiological Health is responsible for assuring the safety of electronic products that emit radiation. Industry is required to submit specific radiation safety reports.

• Radiation-Emitting Products Industry Assistance: Walk-through
• Filing Radiation Safety (Product) Reports for Radiation-Emitting products
• To request a meeting with the Center for Devices and Radiological Health regarding a Radiation-Emitting Product, please provide a proposed agenda, list of attendees, and suggested date and time for the meeting to:

  • Mailing Address:
    U.S. Food and Drug Administration
    Center for Devices and Radiological Health
    OCER/Division of Mammography Quality and Radiation Programs
    10903 New Hampshire Avenue, WO66-4521

  • Phone Number: 301-796-5710
  • Fax Number: 301-847-8502

Tobacco Products

The Center for Tobacco Products (CTP) receives numerous meeting requests each week. Please visit the link below for details on how to request a meeting and an outline of meeting expectations.

• For Industry: How to contact Us or Request a Meeting

Vaccines, Blood, Biologics

The Center for Biologics Evaluation and Research reviews license applications for new biological products, medical devices, and for new indications for already approved products. The Patient Protection and Affordable Care Act signed into law on March 23, 2010, amends the Public Health Service Act to create and abbreviated pathway for biological products. Read more about the types of meetings available for sponsors of biological product applications.

• Biologics License Applications (BLA) Process
• New Drug Application (NDA) Process
• Use of Email for Regulatory Communications
• Information and types of notifications provided to sponsors during the human biologic product application review process
• Premarket Applications (PMAs)
• 510(k)s
• SOPP 8101.1: Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants

User Fee Information

The User Fee program allows FDA to fulfill its mission of protecting the public health and accelerating innovation in the industry. The fees collected are used to support the surveillance of human and animal drugs, medical and mammography devices, color additives, exports, and tobacco products. The Division of User Fees is responsible for the overall management of the program. The team develops and maintains an accounts receivable system used for user fee invoicing and collections, reporting, and data maintenance.

Read more about User Fee Information

Animal and Veterinary

• Animal Drug User Fee Act (ADUFA)
• Animal Generic Drug User Fee Act (AGDUFA)

Drugs

• Prescription User Drug Fee Act (PUDFA)

Foods

• Color Additive Certification Fees

Medical Devices

• Medical Device User Fee and Modernization Act (MDUFMA)

Tobacco Products

• Tobacco Product Fees

Vaccines, Blood, Biologics

• Prescription User Drug Fee Act (PUDFA)

Drugs and Biologics - Types of Meetings

Type A Meeting 
A meeting which is necessary for an otherwise stalled drug development program to proceed (e.g., to address an issue that has resulted in a clinical hold or refuse to file, dispute resolution meetings, special protocol assessment meetings requested by the sponsor/applicant after FDA's evaluation of protocols in assessment letters).

Type B Meeting
Type B meetings include the following: Pre-IND, End of Phase 1, End of Phase 2/Pre-Phase 3, or a Pre- BLA/NDA meeting. Each sponsor/applicant should usually request only one of each of these Type B meetings for each potential application.

Type C Meeting 
Any other type of meeting (e.g., cost recovery, facility design, and general product issues meeting). The Center for Devices and Radiological Health reviews premarket approval applications and 501(k) notifications for new medical devices and devices that are substantially equivalent to already marketed devices.