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                FDA Basics for Industry

FDA Basics for Industry

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          FDA Basics for Industry
          Search DatabasesFDA Basics for Industry Search Databases
  
  	
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Animal Drugs@FDA

	Animal Drugs @ FDA is an online database of FDA-approved animal drugs. It is searchable by NADA/ANADA number, Sponsor, Ingredients, Proprietary name, Dose Form, Route of Administration, Species, ad Indications of Use.
	ADE Report
	The primary purpose for maintaining the FDA/Center for Veterinary Medicine Adverse Drug Experiences (ADE) database is to provide an early warning or signaling system to the Center for adverse effects not detected during pre-market testing of FDA-approved animal drugs and for monitoring the performance of drugs not approved for use in animals.Compliance and Enforcement

Medical Device Compliance and Enforcement Portal

	FDA conducts inspections of medical device manufacturers to ensure they comply with the regulations about device safety and effectiveness. When a medical device violates FDA law, FDA can take action to enforce compliance and ensure public health. Two main tools are Warning Letters and Recalls. In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily).
	Inspections Database
	The Food and Drug Administration (FDA) conducts careful inspections of regulated facilities to determine a firm's compliance with regulations and the Food, Drug and Cosmetic Act. The Agency is disclosing inspection information to help improve the public’s understanding of how the FDA works to protect the public health. Disclosure of the compliance status of firms helps to provide the public with a rationale for the Agency’s enforcement actions and will also help to inform public and industry decision-making, allowing them to make more informed marketplace choices and help to encourage compliance.
	Searchable Warning Letters Database

	A Warning Letter is FDA's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act. Warning Letters are issued to achieve voluntary compliance and to establish prior notice. Search FDA issued Warning Letters by keyword or use our advanced search functionality to search by company, date issued, issuing office, subject, or whether a response letter or closeout letter is posted.
	FDA Debarment List

	Firms or persons convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any new or abbreviated drug application.
	Clinical Investigators - Disqualification Proceedings
	Institutional Review Boards – Restrictions Imposed Letters and Disqualification Proceedings
	FDA Data DashboardDrugs

FDA Adverse Event Reporting System (FAERS) (formerly AERS)

	The FDA Adverse Event Reporting System (FAERS) database contains information on adverse event and medication error reports submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. We provide downloadable files only; you cannot search the database online. Read more about FAERS.
	Bioequivalence (BE) Recommendations for Specific Products
	To receive approval for an Abbreviated New Drug Application (ANDA), an applicant generally must demonstrate, among other things, that its product has the same active ingredient, dosage form, strength, route of administration and conditions of use as the listed drug, and that the proposed drug product is bioequivalent to the reference listed drug (RLD). Our Bioequivalence (BE) Recommendations for Specific Products database provides guidance on how to design BE studies for specific drug products to support ANDAs. Read more about BE recommendations (PDF-80 KB).
	Bioresearch Monitoring Information System (BMIS)
	The Bioresearch Monitoring Information System (BMIS) file contains information submitted to FDA identifying clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug studies with human investigational drugs. Read more about BMIS.
	Clinical Investigator Inspection List (CLIIL)
	The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs. The list contains information on inspections that have been closed since July 1977. Read more about CLIIL.
	Dissolution Methods Database
	For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on dissolution methods presently recommended by the Division of Bioequivalence, Office of Generic Drugs. Read more about the Dissolutions Methods Database.
	Drugs@FDA
	Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products approved since 1998. Read more about Drugs@FDA.
	Inactive Ingredient Search for Approved Drug Products
	Database provides ability to search for inactive ingredients in approved drug products. Read more about the Inactive Ingredients Database.
	National Drug Code Directory
	The current edition of the NDC Directory is limited to prescription drugs and insulin products that have been manufactured, prepared, propagated, compounded, or processed by registered establishments for commercial distribution. The products have been listed in accordance with the Drug Listing Act and regulatory provisions concerning the submission of drug product information to FDA. Read more about the National Drug Code Directory.
	Orange Book (Approved Drug Products with Therapeutic Equivalence)
	The Electronic Orange Book (EOB) Query enables searching of the approved drug list by active ingredient, proprietary name, applicant holder, applicant number or patent. The Approved Drug Products EOB Query web files are downloadable. The files are ASCII text tilde (~) delimited. They are zipped into a self-extracting file, EOBZIP.ZIP. Allow for approximately 5 megabytes for the unzip process. Access files here.
	Postmarket Requirements and Commitments
	Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical trials that sponsors conduct after approval to gather additional information about a product's safety, efficacy, or optimal use. Some of the studies and clinical trials may be required; others may be studies or clinical trials a sponsor has committed to conduct. Read more about the Postmarket Requirements and Commitments database.Food

Search Multiple Food Ingredient and Packaging Inventories
	Substances Added to Food (formerly EAFUS)
	This database includes a list of substances that contain ingredients added directly to food that FDA has either approved as food additives or listed or affirmed as generally recognized as safe (GRAS). It contains only a partial list of all food ingredients that may in fact be lawfully added to food because under federal law some ingredients may be added to food under a GRAS determination made independently from the FDA.
	Food Defense Mitigation Strategies Database (FDMSD)
	The FDMSD is a tool intended to assist those who own or operate companies that produce, process, store, package, distribute, and/or transport food with identifying preventive measures, referred to as mitigation strategies, to protect food against intentional adulteration. The FDMSD provides a range of mitigation strategies that can be used to significantly minimize or prevent vulnerabilities at particular points, steps or processes. The database also provides examples of security measures and procedures that provide an important foundation for a food defense culture throughout the entire facility.
	Generally Recognized as Safe (GRAS) Substance Notices
	This database allows access to opinions and conclusions from 115 reports published between 1972-1980 from the committee of scientists known as the Select Committee on GRAS Substances (SCOGS) on the safety of over 370 Generally Recognized As Safe (GRAS) food substances. The database allows users to search for the SCOGS opinion and conclusion, and includes the United States Code of Federal Regulations (21 CFR) citation for those GRAS food substances that have been codified in the CFR.
	List of Indirect Additives Used in Food Contact Substances
	This database includes a list of certain "indirect" food additives--generally substances that may come into contact with food as part of packaging or processing equipment, but are not intended to be added directly to food--that are found (or, in the case of some of the polymers, are implied) in 21 CFR Parts 175 - 178. The regulation(s) cited for a substance should always be consulted for the complete context before any conclusion is made as to allowed regulated use. Additional "indirect" additives that are effective as part of the food contact substance notification program or that are exempted from regulation as food additives in accordance with 21 CFR 170.39 "Threshold of Regulation (TOR) exemptions for substances used in food-contact articles" are listed in separate inventories.Medical Devices

Medical Device Databases

	This page includes a list of databases relevant to medical devices and radiation-emitting products. The list includes a link to the relevant database, a description of the database, and information as to how frequently the information in the database is updated.Radiation-Emitting Products

Radiation-Emitting Product Codes

	This database contains product names and associated information developed by the Center for all products, both medical and non-medical, which emit radiation. It includes a three letter product code, a descriptor for radiation type, applicable performance standard(s), and a definition for the code.
	X-Ray Assembler Data
	Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly. This database contains the releasable information submitted including Equipment Location, General Information and Component Information.Tobacco

Compliance Check Inspections of Tobacco Product Retailers

	Compliance check inspections of tobacco product retailers are conducted to determine a retailer's compliance with the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act and the Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, found at Title 21 of the Code of Federal Regulations, Part 1140 (21 C.F.R. Part 1140). Results from these inspections covering cigarettes and smokeless tobacco products are available in a searchable database, allowing you to search for inspection reports by tobacco retailer name, city, state, zip code, and decision date. This database is updated monthly.
	Establishment Registration & Tobacco Product Listing database
	Under section 905 of the Federal Food, Drug, and Cosmetic Act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register those establishments with FDA by December 31 of each year. All registrants must also submit a list of all tobacco products which are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling. Registration information is searchable by establishment name, operation type, state, owner name, operator name, and FEI number. Product listing information is searchable by product name and category.Vaccines, Blood, Biologics

Human Cell and Tissue Establishment Registration (HCTERS) Public Query Application

	FDA regulations (21 CFR 1271) require establishments that perform one or more steps in the manufacture of human cells, tissues and cellular- and tissue-based products to register and list their products with the agency. Users can search the HCTERS database for information on establishments that are registered with FDA, including the products manufactured by each. The database includes registration information for registered, inactive and pre-registered firms.
	Adverse Event Reporting System (AERS)
	The Adverse Event Reporting System supports the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. It contains adverse drug reaction reports FDA has received from manufacturers as required by regulation. We provide downloadable files only; you cannot search the database online. Read more about AERS.

                                                                                  Content current as of:
      02/01/2021FDA 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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