Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Development & Approval Process | Drugs

Development & Approval Process | Drugs

                        Clinical Data Summary Pilot Program
          Drug Development Tools | DDTs
          Guidance Documents for Drug Applications
          Laws, Regulations, Policies and Procedures for Drug Applications
          Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)


                        Drug Development Tool (DDT) Qualification Programs
          CDER Small Business & Industry Assistance (SBIA)
          Conducting Clinical Trials
          Development Resources
          Drug Approvals and Databases
          Forms & Submission Requirements
          How Drugs are Developed and Approved
          New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
          Pharmaceutical Quality Resources Home
          Drugs
          Development & Approval Process | Drugs
          Laws, Regulations, Policies and Procedures for Drug ApplicationsDevelopment & Approval Process | Drugs Laws, Regulations, Policies and Procedures for Drug Applications
  
  	
    Share
    Post
    Linkedin

    Email
    PrintThe mission of FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook. *The Federal Food, Drug, and Cosmetic Act* is the basic food and drug law of the U.S.  With numerous amendments, it is the most extensive law of its kind in the world.  The law is intended to assure the consumer that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive.

***Code of Federal Regulations* for Investigational New Drugs (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and Biologics License Applications (BLAs)**

The Code of Federal Regulation (CFR) provide regulations for INDs, NDAs and BLAs.

**Manual of Policies and Procedures (****MaPPs****)**

MaPPs provide official instructions for internal practices and procedures followed by Center for Drug Evaluation and Research (CDER) staff to help standardize the IND and NDA review process. All CDER MaPPs are available from the MaPP Index web page.

                                                                                  Content current as of:
      12/04/2014Development & Approval Process | Drugs

          
                        Clinical Data Summary Pilot Program
          Drug Development Tools | DDTs
          Guidance Documents for Drug Applications
          Laws, Regulations, Policies and Procedures for Drug Applications
          Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)


                        Drug Development Tool (DDT) Qualification Programs
          CDER Small Business & Industry Assistance (SBIA)
          Conducting Clinical Trials
          Development Resources
          Drug Approvals and Databases
          Forms & Submission Requirements
          How Drugs are Developed and Approved
          New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
          Pharmaceutical Quality Resources
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop