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The approval of a new drug application nda by the fda allows for which of the following?
Wiki User
∙ 12y ago
the approval of the new drug application by the fda allows for
Wiki User
∙ 10y ago
Wiki User
∙ 12y agothe answer is a
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What does the acronym ANDA stand for?
ANDA is an acronym for "abbreviated new drug application". This is an application to be used for the approval of a generic equivalent of a currently available drug.
Can a drug have new drug application and an abbreviated new drug application number be the same?
No, a drug can not have new drug application and an abbreviated drug application number can be NOT the same. Source: Experience.
Application of marine biotechnology in production of drug?
application of marine biotechnology in the production of drug application of marine biotechnology in the production of drug application of marine biotechnology in the production of drug
What is the difference between ANDA and NDA?
NDA means New Drug Application. This application is available at the Food and Drug Administration (FDA). When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet the FDA's requirements for marketing approval, the sponsor submits to the FDA a new drug application (NDA). In other words, when a pharmaceutical company creates a new drug, the company must contact the FDA and demonstrate that the new drug has a particular quality and that the drug is safe and effective. In this case, the pharmaceutical company will have to fill out a new drug application (NDA). If the NDA is approved, then the product may be marketed in the United States. The application must contain data from specific technical viewpoints for review. The review is a comprehensive analysis of clinical trial data and other information prepared by the FDA drug application reviewers. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology. For internal tracking purposes, all NDA applications are assigned an NDA number. The NDA number is a six-digit number assigned by the FDA staff to each application for approval to market a new drug in the United States. A drug can have more than one application number if it has different dosage forms or routes of administration. ANDA means Abbreviated New Drug Application. This application is available at the Food and Drug Administration (FDA). An abbreviated new drug application (ANDA) contains data that, when submitted to the FDA, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the original drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the public. For internal tracking purposes, all ANDA applications are assigned an ANDA number. The ANDA number is a six-digit number assigned by the FDA staff to each application for approval to market a generic drug in the United States. A generic drug must be the same as the brand-name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a generic drug product, the FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand-name drug. The FDA bases evaluations of substitutability or "therapeutic equivalence" of generic drugs on scientific evaluations.
What has the author Sandy Weinberg written?
Sandy Weinberg has written: 'Guidebook for drug regulatory submissions' -- subject(s): Drug Approval, Drugs, Drugs, Investigational, Investigational Drugs, Law and legislation, Drug approval
The application for approval of a generic equivalent of an existing proprietary drug must show that the drug?
C: is absorbed from the stomach into the bloodstream at the same rate as the proprietary drug I took this test 7/17/2009 :D B. Stomach I took this test 10/21/2010 (Correct answer)
The symbol that indicates a product is pending FDA approval?
Products pending FDA approval, contains the lightning bolt symbol that identifies codes that are being tracked by the AMA to monitor Food and Drug Administration (FDA) status for approval of a drug.
Investigational new drug IND application contains what.?
the investigational new drug IND application contains what information
How are drugs approved?
The FDA is the organization primarily involved in the medication/drug approval process.
What has the author Tom Brody written?
Tom Brody has written: 'Clinical trials' -- subject(s): Research Design, Clinical Trials Data Monitoring Committees, Drug Approval, Clinical Trials as Topic, Clinical trials, Drug approval
Does a company have to let you know on an application about drug testing?
no
What does FDA approval mean?
It pertains to a food or medical product or process that has applied for approval and received it from the Food & Drug Administration. Go to the FDA website for more precise information about it's mission and authority. FDA link: fda.gov
