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                FDA Basics for Industry

FDA Basics for Industry

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          For Industry
          FDA Basics for Industry
          Product Application and Petition Review ProcessFDA Basics for Industry Product Application and Petition Review Process
  
  	
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    PrintAnimal 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 Animal Devices
	Generic 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: AdministrativeMedical Devices

The Center for Devices and Radiological Health reviews applications for new medical devices and requests to conduct clinical research on patients in the United States. In addition, any medical device that emits radiation is subject to this reporting requirement for radiation-emitting products.

Premarket Notification (510k)
	Investigational Device Exemption(IDE)
	Premarket Approval (PMA)
	Humanitarian Device Exemption
	De Novo
	eCopy Program for Medical Device Submissions
	Obtaining Feedback from CDRH on Medical Device SubmissionsRadiation-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
		OIR/Division of Radiological Health
		10903 New Hampshire Avenue, WO66-4521
		Phone Number: 301-796-5710
		Fax Number: 301-847-8502Tobacco 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 MeetingVaccines, 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 ApplicantsUser 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 FeesMedical Devices

Medical Device User Fee Amendments 2012 (MDUFA III)Tobacco Products

Tobacco Product FeesVaccines, 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.

                                                                                  Content current as of:
      07/12/2016FDA Basics for Industry

          
                        Guidances
          Registration and Listing
          Regulatory Process
          Product Application and Petition Review Process
          Stay Informed With FDA Program Areas
          Search Databases
          Popular Content
          Industry Frequently Asked Questions
          Educational Resources
          Compliance and Enforcement
          For Trade and Industry Groups: Requesting Cross-Agency Speakers From FDA
          Imports
          Submit Questions and Comments
 
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