Drugs@FDA Glossary of Terms | FDA - U.S. Food and Drug Administration
What’s the meaning of this? Welcome to the Drugs@FDA glossary of terms. From abbreviated new drug application to therapeutic equivalence codes, FDA defines it.
FDA Acronyms & Abbreviations | FDA - U.S. Food and Drug Administration
The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities. The emphasis is on scientific,...
Glossary of Terms | FDA - U.S. Food and Drug Administration
Pre-Clinical Data - Before a drug can be tested in people in the United States; sponsors (drug manufacturers, research institutions, and other organizations that develop drugs) must show FDA...
eCFR :: 21 CFR 210.3 -- Definitions.
(1) Act means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.). (2) Batch means a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.
FDA Dashboards - Glossary
The objective of FDA regulatory programs is to ensure compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specific enforcement activities include actions to correct and prevent...
Center for Drug Evaluation and Research - Food and Drug Administration
Both FDA and sponsors should have a common understanding of terms and phrasing used in communication. Use words such as the ones listed below to convey a statutory or regulatory requirement:
FDA | definition of FDA by Medical dictionary
an agency of the United States Department of Health and Human Services whose principal purpose is to enforce the Federal Food, Drug and Cosmetic Act.
Drug Product Drug product means a finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients. 21 CFR 314.3(b) Drug Substance Drug substance means an active ingredient that is intended to furnish pharmacological activity or other
How does FDA define the terms used in this part? - eCFR
Some of the terms we use in this part are specific to medical device reporting and reflect the language used in the statute (law). Other terms are more general and reflect our interpretation of the law. This section defines the following terms as used in this part:
FDA Terminology | CBIIT - Cancer
2024年6月28日 · The U.S. Food and Drug Administration (FDA) is working with Enterprise Vocabulary Services (EVS) to develop and support controlled terminology in these five main areas: Structured Product Labeling (SPL), Unique Ingredient Identified (UNII), Individual Case Safety Report (ICSR), Event Problem Code, and Global Unique Device Identification ...
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