- FDA Acronyms & Abbreviations
- It provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities.
- Approved Risk Evaluation and Mitigation Strategies (REMS)
- Bio-research Monitoring Information System (BMIS)
- 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.
- 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.
Updated: Quarterly, by the fifth working day of April, July, October, and January
- Drug Establishments Current Registration Site
- 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. or offered for import to 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.
- Drug Shortages Searchable Database
- 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.
- [email protected] Search
- Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. [email protected] 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.
- FDA Adverse Event Reporting System (FAERS)
- Inactive Ingredient Search for Approved Drug Products (IID)
- 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.
Update: Quarterly, by the tenth working day of April, July, October, and January
- 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.
- Not all inactive ingredients will have a UNII. 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. More information about the UNII and the SRS is available at Substance Registration System – Unique Ingredient Identifier (UNII).
- 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.
- 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.
- Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) Search
- 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.
- Post-market 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.
Key Takeaways – At a Glance
|01||Bioresearch Monitoring Information System (BMIS)||Quarterly|
|02||Dissolution Methods Database||Quarterly|
|03||Drug Establishments Current Registration Site (DECRS)||Annually b/n Oct 1st and Dec 31st of each year|
|04||Inactive Ingredient Search for Approved Drug Products (IID)||Quarterly|
|05||National Drug Code Directory||Daily|
|07||Post-market Requirements and Commitments||Quarterly|