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New Drug Application Hardcopy

New Drug Application Hardcopy

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Published by GANESH KUMAR JELLA
pharmacy powerpoint presentations
pharmacy powerpoint presentations

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Categories:Types, Research, Science
Published by: GANESH KUMAR JELLA on Jun 23, 2011
Copyright:Attribution Non-commercial

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04/28/2013

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ABSTRACT 
The NDA is a vehicle seeking approval to the new product after the completion of carefully design preclinical and clinical studies. The FDA’s approval of an NDA indicates thatthe body of scientific evidence submitted sufficiently demonstrating the drug or the drug products safety efficacy for the proposed chemical indications showing adequate assurance of its proper manufacture control and final labelling and accurately necessary information for its proper use. An Abbreviated New Drug Application (ANDA) is an application for generic drugapproval for an existing licensed medication or approved drug. It provides documentation onchemistry manufacturing controls, bioavailability of the proposed product to demonstrate biological equivalency to the product.
 
NEW DRUG
A combination of two or more old drugs or a change in the usual proportions of drugs inan established combinations product is considered new if the change introduces aquestion of safety or efficacy.According to FDA, a new drug is any that is not recognized as being safe and effectivein the conditions recommended for it use among experts who are qualified by scientifictraining and experience.A proposed new use for an established drug, a new dosage schedule of regimen , a newroute of administration, or a new dosage form all cause a drug or drug products status tonew and triggers reconsideration for safety and efficacyA change in a previously approved drug products formulation or method of manufactureconstitutes newness under the law.
NEW DRUG DEVELOPMENT PROCESS
 New chemical entity
Pre clinical studies
Investigational new drug application(IND)
Clinical trials
 New drug application.
Post marketing surveillance
 
Investigational New Drug Application (INDA):
Current Federal law requires that a drug be the subject of anapproved marketing application before it is transported or distributed across state lines. Becausea sponsor will probably want to ship the investigational drug to clinical investigators in manystates, it must seek an exemption from that legal requirement. The IND is the means throughwhich the sponsor technically obtains this exemption from the FDA.During a new drug's early preclinical development, thesponsor's primary goal is to determine if the product is reasonably safe for initial use in humans,and if the compound exhibits pharmacological activity that justifies commercial development.When a product is identified as a viable candidate for further development, the sponsor thenfocuses on collecting the data and information necessary to establish that the product will notexpose humans to unreasonable risks when used in limited, early-stage clinical studies.FDA's role in the development of a new drug begins when thedrug's sponsor (usually the manufacturer or potential marketer) having screened the newmolecule for pharmacological activity and acute toxicity potential in animals, wants to test itsdiagnostic or therapeutic potential in humans. At that point, the molecule changes in legal statusunder the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specificrequirements of the drug regulatory system.There are three IND types:
An Investigator IND is submitted by a physician who both initiates and conducts aninvestigation, and under whose immediate direction the investigational drug isadministered or dispensed. A physician might submit a research IND to propose studyingan unapproved drug, or an approved product for a new indication or in a new patient population.
Emergency Use IND allows the FDA to authorize use of an experimental drug in anemergency situation that does not allow time for submission of an IND in accordancewith 21CFR , Sec. 312.23 or Sec. 312.34. It is also used for patients who do not meetthe criteria of an existing study protocol, or if an approved study protocol does not exist.

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