The Food and Drug Administration (FDA) is the federal system that approves any drug related to humans. The Agency provides the sufficient information that enables the sponsors and industry to gather the data and requirements from time-to time. These data can be used as a regulatory intelligence tool to understand the agency’s current thinking and meet the applicable requirements and keep focus on the competitor analysis.
There are several databases in the FDA to track the necessary information as part of regulatory intelligence. Some of the important tools and databases are provided below.
Classification of FDA Databases
The FDA databases can be classified into various categories based on the information and stage of the pharmaceutical product lifecycle.
Portfolio & Business:
- Drugs@fda
- National Drug Code Directory
- Orange Book
- Purple Book
- Drug Shortages
- PEPFAR Database
Research & Development:
- Product Specific Guidance
- Dissolution Methods Database
- Inactive Ingredients Database
Facilities & Compliance:
- Inspection Database
- Warning Letter Database
- Debarment List
- Drug Establishments and Current Registrations
- Post marketing requirements and commitments
Clinical & Safety:
- Bioresearch Monitoring Information System
- Clinical Investigator Inspection List
- Risk Evaluations & Mitigation Strategies
- FAERS
- Drug safety-related Labelling Changes
- Medication Guide
Portfolio & Business:
1. 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.
Access Link: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
Frequency of Update: Daily
2. National Drug Code Directory
The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)). Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory.
Access Link: https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm
Frequency of Update: Daily
The information submitted as part of the listing process, the NDC number, and the NDC Directory are used in the implementation and enforcement of the Act.
3. Orange Book
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).
It contains the list of drug products, approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.
Access Link: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
Frequency of Update: Daily
4. Purple Book
The Purple Book is a searchable database that contains information about biologicals, biosimilars and interchangeable biological products approved by FDA. It usually contains two separate lists of FDA-licensed biological products regulated by the Center for Drug Evaluation and Research (CDER) and FDA-licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER).
Currently, the database contains FDA-licensed biological products regulated by CDER, including licensed biosimilar and interchangeable products, and their reference products, and FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by CBER.
Access Link: https://purplebooksearch.fda.gov/
Frequency of Update: Daily
5. Drug Shortages
FDA created this searchable database to provide stakeholders with easy access to information about drugs in shortage, such as product availability, supply, and estimated duration of shortage. The database includes information about current drugs in shortage, resolved shortages, discontinuations of specific drug products, corresponding therapeutic categories, resource information, and relevant links.
Access Link: https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
Frequency of Update: Daily
6. PEPFAR Database
The United States President’s Emergency Plan for AIDS Relief (PEPFAR) is the U.S. Government’s initiative led by the Department of State’s Office of the U.S. Global AIDS Coordinator and Global Health Diplomacy (S/GAC) to address the HIV/AIDS epidemic around the world and help save the lives of those suffering from the disease.
The FDA’s CDER reviews marketing applications for ARVs for the PEPFAR program through a Tentative Approval/Approval Program. PEPFAR only procures ARVs that have been granted tentative approval or approval by CDER to be distributed outside the United States.
Access Link: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=pepfar.page
Frequency of Update: Daily
Research & Development:
1. Product Specific Guidance
The generic product must demonstrate the product has the same active ingredient, dosage form, strength and route of administration along with conditions of use as per the reference listed drug and the same has to prove the proposed product is bio-equivalent to listed drug to receive an approval as ANDA.
The database provides recommendations on how to design the BE studies for specific drug products in support of the ANDA and guides the sponsor to prepare and conduct the bioequivalence studies.
Access Link: https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm
Frequency of Update: Bi-weekly
2. Dissolution Methods Database
For a drug product that does not have 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.
The “Recommended Sampling Times” field specifies the times recommended for taking dissolution samples for a particular drug product to generate a dissolution profile.
Access Link: https://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm
Frequency of Update: Quarterly, by the fifth working day of April, July, October, and January.
3. Inactive Ingredients Database
The Inactive Ingredient Database provides information on inactive ingredients present in FDA-approved drug products. For new drug development purposes, once an inactive ingredient has appeared in an approved drug product for a particular route of administration, the inactive ingredient is not considered new and may require a less extensive review the next time it is included in a new drug product.
Access Link: https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
Frequency of Update: Quarterly, by the tenth working day of April, July, October, and January
UNII
The acronym “UNII” stands for “Unique Ingredient Identifier”. The UNII is a part of the joint United States Pharmacopeia (USP)/FDA Substance Registration System (SRS), which has been designed to support health information technology initiatives by providing unique identifiers for substances in drugs, biologics, foods, and devices based on molecular structure and/or descriptive information.
The SRS is used to generate permanent, unique, unambiguous identifiers for substances in regulated products, such as ingredients in drug products. The UNII is being displayed in association with inactive ingredients to facilitate Structured Product Labeling (SPL), which requires that a UNII be used for all ingredients, including inactive ingredients.
In order to receive a UNII, an ingredient must be a ‘substance’, which is defined as “Any physical material that has a discrete existence, irrespective of origin.” Products will not be assigned a UNII.
Access Link: https://precision.fda.gov/uniisearch
Facilities & Compliance:
1. Inspection 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 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.
Access Link: https://datadashboard.fda.gov/ora/cd/inspections.htm
Frequency of Update: Weekly
2. Warning Letter 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.
Frequency of Update: Daily
3. 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.
4. Drug Establishments and Current Registrations
The Drug Establishments Current Registration Site (DECRS) is a database of current information submitted by drug firms to register establishments (facilities) which manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. Establishments must be registered within 5 days of beginning operations. In addition, establishments must renew registration annually between October 1st and December 31st of each year. In addition, at the time of annual registration, firms must list any drugs not previously listed and should make any updates to existing listing information.
Access Link: https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm
Frequency of Update: Daily
5. Post-marketing Requirements and Commitments
It provides information to the public on post-market requirements and commitments. The phrase post-market requirements and commitments refer 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.
Access Link: https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm
Frequency of Update: Quarterly
Clinical & Safety:
1. Bio-research Monitoring Information System
It contains information that identifies clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug (IND) studies with human investigational drugs and therapeutic biologics.
The Bioresearch Monitoring Information System (BMIS) file contains information submitted to FDA identifying clinical investigators (CIs), contract research organizations (CROs), and institutional review boards (IRBs) involved in the conduct of Investigational New Drug (IND) studies with human investigational drugs.
The information has been abstracted from FDA Forms 1571 and 1572 and other pertinent documents contained in IND submissions (e.g., C.V.s, cover letters, investigator lists, etc.). Please note that this file contains a separate entry for each time an investigator, CRO or IRB is identified in a new submission.
Access Link: https://www.accessdata.fda.gov/scripts/cder/bmis/index.cfm
Frequency of Update: Quarterly
2. Clinical Investigator Inspection List
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.
Access Link: https://www.accessdata.fda.gov/scripts/cder/cliil/index.cfm
Frequency of Update: Quarterly
3. Risk Evaluations & Mitigation Strategies
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication. While all medications have labeling that informs healthcare stakeholders about medication risks, only a few medications require a REMS.
Access Link: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm
Frequency of Update: As and when updates to REMS drugs
4. FDA Adverse Event Reporting System
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.
Frequency of Update: Quarterly
5. Drug safety-related Labeling Changes
The Drug Safety-related Labeling Changes (SrLC) database includes updates to safety information in labeling for NDAs and BLAs.
The database includes changes to safety information in the prescribing information, patient counseling information/patient information/medication guide. The database has two searches options: A Search Labeling by
- Drug Name
- Date Range
This website provides these safety information to the public, including health care vendors who integrate these important prescription drug labeling updates into systems frequently accessed by health care practitioners and/or patients.
Access Link: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm
Frequency of Update: Daily
6. Patient Labeling Resources
The patient labeling resources are the detailed instructions on the usage of the medicinal products. These resources are developed by applicant, reviewed and approved by FDA to issue to the patient or caregiver when the drug is dispensed.
Three types of resources are available:
- Medication Guide (MG)
- Patient Package Insert (PPI)/Patient Information (PI)
- Instructions for Use (IFU)
A medication guide is a patient labeling provided for prescription drugs that could help prevent serious adverse reactions, where Patient adherence to directions for use is crucial to the drug’s effectiveness and to enlighten the patient on the information concerning the risk(s) could affect patients’ decision to use, or to continue to use, the product.
PPIs are required for oral contraceptives and estrogen-containing products
The IFU provides detailed, action-oriented, step-by-step written and visual instructions for the patient on how to use the drug including instructions on preparation, administration, handling, storage, and disposal.
Access Link: https://nctr-crs.fda.gov/fdalabel/ui/search
Frequency of Update: Daily
SUMMARY OF FDA DATABASES & ACCESS LINKS
