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U.S. Department of Health and Human Services

For Industry

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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.

 

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:

 

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.

 

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.

 

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.

 

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.

 

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.

 

 

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

Drugs

Foods

Medical Devices

Tobacco Products

Vaccines, Blood, Biologics

 

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.