DRUG APPROVALS Meaning and
Definition
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Drug approvals refer to the process through which a pharmaceutical drug is granted regulatory authorization to be marketed and sold for use in the treatment, prevention, or diagnosis of a specific medical condition. This process involves rigorous evaluation, scrutiny, and assessment of the drug's safety, efficacy, and quality by regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.
The drug approval process typically begins with preclinical studies conducted in laboratories and animal models, followed by clinical trials involving human participants. These trials aim to determine the drug's effectiveness, dosage requirements, potential side effects, and interactions with other drugs, among other factors. Data from these trials is then compiled and submitted to regulatory authorities for review.
During the approval process, regulatory agencies assess the submitted data to determine if the drug's benefits outweigh its risks, if it meets the necessary quality standards, and if the manufacturer's proposed labeling and instructions for use are appropriate. This evaluation involves scrutiny of data from preclinical and clinical studies, as well as the drug's manufacturing processes, formulation, and proposed indications.
Once a drug is approved, it can be marketed and prescribed by healthcare professionals for use in patients. However, drug approvals are not permanent, and regulatory bodies continuously monitor post-marketing safety data, requiring manufacturers to report adverse events and conduct additional studies if necessary.
In summary, drug approvals encompass the comprehensive evaluation and authorization process that ensures the safety, efficacy, and quality of pharmaceutical drugs before they are made available for patient use.
Common Misspellings for DRUG APPROVALS
- srug approvals
- xrug approvals
- crug approvals
- frug approvals
- rrug approvals
- erug approvals
- deug approvals
- ddug approvals
- dfug approvals
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- d5ug approvals
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- dryg approvals
- drhg approvals
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- drig approvals
- dr8g approvals
- dr7g approvals
- druf approvals
- druv approvals
Etymology of DRUG APPROVALS
The etymology of the word "drug approvals" can be understood by breaking it down into its constituent parts.
The word "drug" originated from the Middle English word "drogge" or "droog", which meant a medicinal substance. It can be traced back to the Dutch word "droge", meaning "dry", which referred to the plants or herbs used in medicines. This Dutch term is ultimately derived from the French word "drogue", meaning "supply" or "lazy".
The term "approval" comes from the Latin word "approbatio", which means "approval" or "praise". It is derived from the verb "approbare", meaning "to approve", which combines the prefix "ad-" (to) and "probrare" (to prove or demonstrate).
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